Regulatory Affairs Specialist Resume Samples

4.6 (107 votes) for Regulatory Affairs Specialist Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the regulatory affairs specialist job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Resume Builder
CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Create a Resume in Minutes
HG
H Gulgowski
Hailee
Gulgowski
71087 Eulah Harbors
Boston
MA
+1 (555) 760 7599
71087 Eulah Harbors
Boston
MA
Phone
p +1 (555) 760 7599
Experience Experience
Philadelphia, PA
Regulatory Affairs Specialist
Philadelphia, PA
Mosciski-Labadie
Philadelphia, PA
Regulatory Affairs Specialist
  • Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System
  • Assist regulatory management in the implementation and delivery of CMC regulatory documentation
  • Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions
  • Management of new product development and registration projects and for conducting routine regularoty operations to ensure compliance
  • Assist in developing regulatory strategies
  • Identify opportunities to implement process and procedural improvements to drive efficiency within a growing digital health organization
  • Excellent training and development programs as well as opportunities to grow within the company
Houston, TX
Senior Regulatory Affairs Specialist
Houston, TX
Wuckert-Fay
Houston, TX
Senior Regulatory Affairs Specialist
  • Ensuring collaboration across RSU, including communication with regions and countries
  • Ensuring overall project efficiency and adherence to project timelines and financial goals
  • Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
  • Advertising and promotion
  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
  • Assisting with the creation and review of core scientific, technical and administrative documentation
  • Developing and implementing the RSU Management Plan
present
Dallas, TX
Principal Regulatory Affairs Specialist
Dallas, TX
Fritsch and Sons
present
Dallas, TX
Principal Regulatory Affairs Specialist
present
  • Assists management in the monitoring of state and federal regulatory and legislative development to identify issues affecting company's operations and plans
  • Establish and maintain good working relationship with regional RA peers and local business units to gain positive and timely support
  • Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues
  • Develop regulatory plans and departmental positioning in collaboration with the Manager and Director of Regulatory Affairs and Design Assurance
  • Follow all work/quality procedures to ensure quality system compliance and high quality work
  • Provide regulatory guidance for product development and planning throughout the product lifecycle
  • Develop worldwide regulatory strategies/plans and lead implementation. Provide on-going expertise to teams for regulatory issues and questions
Education Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
Florida Atlantic University
Bachelor’s Degree in Science
Skills Skills
  • A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
  • Good organizational and time management skills; ability to adhere to timelines
  • Good knowledge Global Regulatory Affairs Procedures
  • Producing weekly and monthly regulatory reports for both internal EY stakeholders across service lines as well as external committee chairs and boards, ensuring that material aspects of regulatory changes and or developments are highlighted (actual or potential)
  • Maintaining an up to date and traceable consultation tracker to provide an auditable view on the regulatory consultations identified as relevant to our market, our business and our clients (PMO)
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Very strong attention to detail
  • Excellent communication and team leadership skills with strong managerial skills
  • Excellent writing, communication, and interpretive skills
Create a Resume in Minutes

15 Regulatory Affairs Specialist resume templates

1

Product Regulatory Affairs Specialist Resume Examples & Samples

  • Product Stewardship
  • Product Safety
  • Classify chemicals per regulatory requirements
  • Assist with development of standard operating procedures and work rules
  • Assist with continuous process improvement for safety data sheet authoring process
  • 5 years of relevant experience required
  • Familiarity with SDS authority software, WERCs
  • Familiarity with consumer goods manufacturing processes and safety issues
  • Strong undergraduate coursework in Chemistry, including Inorganic Chemistry, Organic Chemistry and Calculus
  • Product Stewardship and Product Safety professional experience
  • Willing to accommodate local travel to meet with clients
  • Masters degree preferred
  • Previous employment with or involving a consumer goods manufacturing company (i.e. pharmaceuticals, household items, cosmetics & personal care companies)
  • Familiarity with GHS / Purple Book / OSHA HCS a plus
  • Ability to apply rules to derive chemical classifications
  • Experience with consumer goods and/or personal care manufacturing preferred
  • Experience with the pharmaceutical experience preferred
2

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Plan and coordinate manager and wider team meetings, including agenda and presentations
  • Support inputs for quarterly management and functional review meetings
  • Act as a central point for regulatory changes within the region as well as appropriate communication to the business
  • Act as delegate for the Director of Regulatory Affairs as required
  • Act as supporting resource in regulatory activities associated with business initiatives including coordination with outside consultants
  • Developing working knowledge of associated business initiative regulations and act as a voice for regulatory requirements on a project by project basis
  • Support the region in relation to advocacy activities and work with SMEs to lobby change in areas impacting the business
  • Establish and maintain good working relationship with regional RA peers and local business units to gain positive and timely support
  • Serve as regulatory consultant to marketing and government teams as required
  • Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal quality system and policy
  • Supports Director of Regulatory Affairs to carry out responsibilities for the region as required
  • A seasoned, experienced regulatory professional with medical devices and associated regulatory experience (5+ yrs minimum)
  • Solid understanding of EU medical device regulations
  • Experience of environmental regulations would be advantageous
  • Demonstrates a working knowledge of EU and European wide advocacy, including revised Medical Device Regulation
3

Associate Regulatory Affairs Specialist Resume Examples & Samples

  • Assists in Supplier Quality activities, with focus on obtaining Supplier ingredient documentation related to but not limited to Country of Origin, Allergens, Kosher, Halal, Organic, and Non GMO
  • Product registrations where applicable
  • Reviews Foodservice/Chain product related artwork routed through Blue
  • Assists in special projects related to LW Foodservice/Chain labels and packaging
  • Assists in the shipping and handling of nutrition samples as well as the maintenance of the RA /Nutrition SharePoint site with the incoming nutrition data
  • Assists in the maintenance of the ESHA/Genesis software database
  • Assists with other RA/Nutrition projects in a coordinated, prioritized and timely manner
  • Must be able to sit for periods of time, up to 4 hours
  • Must be able to drive a company or rental vehicle for up to 8-10 hours or 300 – 500 miles
4

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Plan & execute global regulatory activities necessary to obtain and maintain regulatory clearances/approvals within the domestic and International markets. In this role, you will ensure compliance with relevant FDA, MDD, ISO and other global regulations for Sciex’s products
  • You will lead FDA pre-submission meetings, IDE’s, develop FDA regulatory strategies, author 510(k) submissions, and negotiate requirements/questions needed to gain FDA 510(k) clearance
  • Provide regulatory guidance for product development and planning throughout the product lifecycle
  • Active participation on internal development teams (core teams), providing US and/or International regulatory strategy and execution. Identify needs for bench, animal, and clinical testing
  • Provide regulatory review of labeling and advertising, design changes, and specification changes
  • Assist in keeping company informed of regulatory requirements in the US
  • Prepare regulatory filings such as 510(k), IDE, Pre-Submission meetings, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines
  • Identify need for new regulatory policies, processes and SOPs. Drives the execution of said documents
  • Monitor and submit applicable reports and responses to regulatory authorities
  • Maintain annual licenses, registrations and listings
  • Ensure compliance with product post-marketing approval requirements
  • Review and approve required reports, supplemental submissions and other post marketing commitments
  • Evaluate post-market incident reports and determine MDR requirements. Report adverse events to internal stakeholders
  • Prepare and facilitate collection of necessary information for post-market health hazard evaluations, recall evaluations, MDR evaluations
  • Provide regulatory input for UDI compliance requirements
  • Minimum Education - Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • 510(k), IDE or PMA experience
  • Strong communications skills
  • Strong technical writing skills
  • Minimum Experience / Training Required
  • 7+ years of experience preferred
  • LI-JM1
5

Associate Regulatory Affairs Specialist Resume Examples & Samples

  • 1 year regulatory/clinical experience at a medical device company or 1+ year(s) related experience and training
  • Microsoft applications, which includes working with templates, and editing and formatting complex documents
  • Competency with various software packages: (Word, PowerPoint, Visio, Excel, Access, Internet, HTML code)
  • Working knowledge and/or experience working in SAP or other related system
  • Experience with Documentum, Agile or other document management systems used in the medical device/pharmaceutical industry
  • Advanced knowledge level of Microsoft applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
  • Experience with Internet/Intranet technology and interactive software applications
  • Flexible with priorities and responsibilities
  • Effective organizational skills and attention to detail
  • Regulatory or Quality department experience
  • Works well under pressure in a dynamic environment
  • General knowledge of industry practices, techniques and standards
6

Senior Regulatory Affairs Specialist Patient Care Resume Examples & Samples

  • B.S. or B.A. degree required. MS or MBA preferred
  • Minimum 5+ years of Regulatory Affairs experience required
  • Minimum of 3+ years of experience in the medical device industry. Combination product experience preferred
  • Must have experience with US and European medical device submissions, regulations, and standards
  • Must have directly authored 510(k)s and have experience in preparing other regulatory documents (i.e. EU Technical File or Design Dossier)
  • Must have experience interacting with FDA and/or other regulatory agencies
  • Must have a solid understanding of manufacturing and change control, and an awareness of regulatory trends
  • Must possess strong technical writing skills and analytical ability
  • Must possess strong communication skills and ability to work collaboratively in a team environment
7

Principal Regulatory Affairs Specialist, NDT Resume Examples & Samples

  • Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field
  • Experience in developing regulatory strategies and preparing regulatory submissions (domestic and international) for Class II and Class III (FDA classification scheme) medical devices
  • Experience in IDEs, PMAs, 510(k)s, Amendments, Supplements, Annual Reports, 30 day Notices, Real Time Reviews, 180 Days, Design Dossiers, Technical Files and Notification to Notified Bodies
  • Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
  • Experience with regulatory support of clinical trials
  • Have detailed knowledge of international medical device regulatory requirements
  • Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
  • Works well under pressure in a dynamic timeline-driven environment
8

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • B.S. or B.A. degree required. MS or MBA preferred
  • 5+ years of Regulatory Affairs experience
  • 3 years of experience in the medical device industry
  • Must have authored 510(k)s
  • Must have knowledge of US, European/International regulations and standards
  • Experience in preparing regulatory submissions
  • Experience interacting with FDA and/or other regulatory agencies
  • Must work well in team environments
  • Must demonstrate leadership skills in team setting
  • Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends
9

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • 9 - 13 years of experience within medical device industry in a regulatory and/or quality function. Cross-functional experience preferred
  • Demonstrated ability to provide guidance and mentoring to less experienced colleagues and cross-functional team members. Viewed as an expert in regulatory matters
  • Expert knowledge of medical device regulations with an emphasis on FDA and MDD. Experience with additional international regulations preferred
  • Extensive 510(k), IDE, PMA, EU MDD 93/42/EEC Technical File/Design Dossier (original/revision/supplements) preparation, review, and submission experience
  • Extensive experience interacting directly with FDA, EU, Japanese PMDA, and other regulatory bodies' reviewers/inspectors
  • Experience representing the company/industry as an active member of AdvaMed, OSMA, etc
  • Demonstrated understanding of the FDA device listing and establishment registration process
  • Demonstrated ability to work effectively in a team based environment
  • Demonstrated excellent interpersonal, written, oral, communication, organizational and planning skills
  • Demonstrated knowledge of MS office suite (Word, PowerPoint, Excel and Access)
  • Excellent understanding of scientific principles
  • Serve as RA expert and make autonomous decisions on complex product development teams to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process
  • Serve as a divisional expert on regulatory matters and provide guidance and mentoring to less experienced colleagues and cross-functional team members
  • Evaluate medical device regulations and develop strategies for bringing products to market
  • Remain informed regarding new regulations or changes to existing regulations and communicate pertinent information to project teams and RA management
  • Provide expert review of FDA submissions, design dossiers, technical files, and other regulatory documents
  • Author FDA submissions, design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market
  • Develop EU technical files to meet the requirements of MDD93/42EEC and support granting the CE mark
  • Interface and coordinate directly with FDA, notified body reviewers, and other regulatory agencies on submissions approvals or other issues
  • Ensure project team(s) and RA management remain informed regarding all regulatory agency/notified body correspondence
  • Author post market submissions (progress reports, annual reports etc.)
  • Review labeling and marketing literature for compliance to regulatory requirements
  • Review Quality System procedures for regulatory impact
  • Prepare and update US product listings
  • Support Marketing, R&D and Manufacturing teams with regulatory assessments of proposed changes or product transfers
  • Review and approve change documentation while considering US, EU and other international regulatory requirements
  • Represent the company/industry as an active member of AdvaMed, OSMA, etc
  • Provide regulatory support for audits
  • Lead the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products
  • Ensure that all regulatory information systems remain accurate and readily accessible. Lead changes to the systems where required
  • Lead divisional improvement activities and transactional LEAN projects
10

Quality Assurance & Regulatory Affairs Specialist Resume Examples & Samples

  • Manage and establish / maintain compliance with FDA QSRs (GMP) including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system
  • Responsible for the Documentation Control Process, and Engineering Change Control Process
  • Establish / maintain compliance with the EU IVD directive and other international regulations and standards as required, including registrations
  • Maintain Technical Documentation files in compliance with international requirements
  • Responsible for working with R&D and Manufacturing to develop validation protocols for production processes and generating the final report, covering the validation results and a recommendation for approval or disapproval for the release of the process to Manufacturing
  • Ensure compliance of labeling and advertising for all products in a regulated class
  • Support the QMS training program, including applicable QMS and regulatory requirements, and act as a resource to ensure quality and regulatory compliance
  • Monitor and trend key quality objectives and present data to Senior Management during management review meetings
  • Conduct internal audits and ensure closing of findings
  • Responsible for supporting Management Review with metrics data on change requests and Quality Documents and supporting timely document search and delivery during audits
  • Travel up to 25% is required
  • 5+ years of experience in Quality Assurance and Regulatory Affairs for Medical Devices
  • Experience in scheduling and performing internal audits and auditing vendor quality systems, writing standard operating procedures and work instructions, developing and Implementing Management Control Systems, and maintaining CAPA system
  • Experience with Canadian ISO 13485 and all international market medical device requirements is a plus
  • Good working knowledge of Microsoft Office software
  • Excellent communication and interpersonal skills with a customer-oriented focus
  • Strong ability to handle multiple priorities simultaneously
  • Meticulous attention to detail and accuracy and the ability to clarify areas of ambiguity
  • Ability to be a self-motivated multi-tasker and ability to work in a team environment
11

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Provide assistance in organizing and maintaining key functions for regulatory affairs
  • Coordinate the review and assemble regulatory submissions (NDAs, INDs), amendments and post-approval supplements including review and evaluation of supporting documentation for accuracy and conformance with the applicable ICH and FDA regulations and guidances
  • Work closely with the manager, Regulatory Affairs to compile and review annual reports, drug history and establishment registrations to ensure accuracy and completeness prior to submission to FDA
  • Assess the change control proposals/packages to determine the appropriate regulatory mechanism and appropriate documentation for submission to regulatory agencies
  • Coordinate submission of responses to Health Authority inquiries and regulatory submissions
  • Provide regulatory support for the review and approval of labeling
  • Assist in the preparation and review of departmental SOPs on an ongoing basis
  • Maintain department tracking/control systems and monitor them for improvement
  • Perform other duties as assigned or approved by the Group Head Regulatory Affairs
  • Good working knowledge of drug approval process; experience with drugs and medical device submissions preferred
  • Strong organizational and project management capabilities required; effective oral and written communications skills required
12

Associate / Regulatory Affairs Specialist Resume Examples & Samples

  • Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
  • Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications)
  • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA
  • Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTED, International Dossier)
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions
  • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests
  • Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy
  • Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies
  • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities
  • Support due diligence and business integration activities as assigned
  • Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned
  • Bachelors of Science required, with emphasis on life science or engineering
  • Associate RA Specialist: Minimum of 0 to 3 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers)
  • RA Specialist: Minimum of 3 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers)
  • Previous experience in supporting regulatory projects and R&D/Quality teams
  • Solid knowledge in FDA, EU regulations for medical device
  • Good oral and written communications skills and ability to work on cross-functional teams
  • Working knowledge of statistics and electronic documentation and information systems
  • Professional certifications preferred
  • Advanced Degrees preferred
13

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
  • Understand; investigate and evaluate regulatory history/background of class; disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
  • Determine trade issues to anticipate regulatory obstacles
  • Determine and communicate submission and approval requirements
  • Participate in risk-benefit analysis for regulatory compliance
  • Assess the acceptability of quality; preclinical and clinical documentation for submission filing
  • Compile; prepare; review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies
  • Monitor applications under regulatory review
  • Monitor and submit applicable reports to regulatory authorities
  • Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Maintain annual licenses; registrations; listings and patent information
  • Assist compliance with product post marketing approval requirements
  • Review and approve advertising and promotional items to ensure regulatory compliance
  • Assess external communications relative to regulations
  • Review regulatory aspects of contracts
  • Assist with label development and review for compliance before release
  • Submit and review change controls to determine the level of change and consequent submission requirements
  • Analyze the input of cumulative product changes to current product submissions
  • Contribute to the development and functioning of the crisis/ issue management program
  • Ensure product safety issues and product-associated events are reported to regulatory agencies
  • Provide regulatory input for product recalls and recall communications
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals)
14

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Medical writing
  • Advertising and promotion
  • Labeling
  • Controlled substances (e.g. DEA)
  • Restricted substances (e.g. REACH)
  • Compendial / standards
  • Import / export
  • Country specific regulatory support
  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Regulatory agency structure, processes and key personnel
  • Principles and requirements of applicable product laws
  • Submission/registration types and requirements
  • GxPs (GCPs, GLPs, GMPs)
  • Principles and requirements of promotion, advertising and labeling
  • International treaties and regional, national, local and territorial trade requirements, agreements and considerations
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process
  • Communicate effectively verbally and in writing
  • Communicate with diverse audiences and personnel
  • Write and edit technical documents
  • Work with cross-functional teams
  • Work with people from various disciplines and cultures
  • Negotiate internally and externally with regulatory agencies
  • Pay strong attention to detail
  • Manage projects
  • Create project plans and timelines
  • Think analytically
  • Organize and track complex information
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Has broad knowledge of various technical alternatives and their potential impact on the business
  • Exercise good and ethical judgment within policy and regulations
  • Use in-depth knowledge of business functions and cross group dependencies/ relationships
  • Define regulatory strategy with supervision
  • Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
15

Regulatory Affairs Specialist Resume Examples & Samples

  • Contribute to local Innovation and Renovation (I&R) projects and support Canadian market launches
  • Ensure regulatory compliance of formulations, raw materials and finished products, labelling and any brand communication to consumers and healthcare professionals by working in close collaboration with Marketing, Medical Affairs, Technical Application Group, Quality, Legal, US and global counterparts
  • Approve all product related claims and coordinate substantiation dossiers where required. Provide regulatory support and guidance to local and global internal networks
  • Prepare and coordinate regulatory submissions for licensing and health authority engagement; prepare responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and positive assessments. Keep the business informed of submission status and outcome
  • Keep abreast of the Canadian regulatory environment and significant international developments from health agencies (such as the US FDA), scientific authorities (such as IOM and EFSA), and international standard setting organizations, sharing this regulatory knowledge internally
  • Propose and implement validated action plans in response to external regulatory changes and from Nestlé’s global initiatives
  • Participate in industry working groups and discussions with local authorities on specific issues
  • University degree in Science or related discipline is required. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets
  • Minimum 3 years of experience in Regulatory Affairs in regulated health products, food and beverage or CPG regulations. Familiarity with the Food and Drugs Act and Food and Drugs Regulations is essential
  • Applied knowledge in at least one of the regulatory topics of NHPs (highly preferred), Foods for Special Dietary Use or Infant Formula (highly preferred), supplemented or fortified foods, self-care products or a product category involving regulatory submissions
  • Knowledge and experience in nutritional science, product formulations (raw materials through finished products) and advertising standards in a scientific and regulatory context
  • Exceptional organizational & efficiency skills – ability to organize work, multi-task, create detailed plans, monitor progress, follow-up and meet deadlines
  • Excellent oral and written communication and interpersonal skills
  • Demonstrates initiative and is proactive; ability to work independently, anticipate needs and be forward- thinking
  • Advanced Microsoft Office skills, including Outlook, Excel, Word and PowerPoint
  • Bilingualism (English & French) is an asset
16

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Provides strategic and technical leadership in assigned areas
  • Represent ConAgra’s interests in external forums in areas of assigned responsibility
  • Implements and provides ongoing management for processes and procedures within assigned technical area(s) of responsibility
  • Provides day-to-day technical support to ConAgra partners in Supplier Quality, Procurement, Platform Quality, and Enterprise Food Protection & Regulatory Affairs associated with assigned areas
  • Develops technical evaluations and analysis of data in managing situations and issues relative to assigned areas
  • Provides technical expertise to Escalated Incidents and Special Situation (EISS) program and provides oversight to corrective actions
  • Evaluates effectiveness and assures continuous improvement in assigned areas of responsibility
  • Collaborates with other departments to develop and implement policies and procedures, and training for topics in area of assigned responsibility within corporate and plants
  • Office
17

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues
  • Participates in cross-functional teams to implement the regulatory strategies for the timely support of project team goals
  • Ensures that product development projects and changes to existing products are conducted in compliance with the appropriate regulations
  • Participates in document review process by reviewing documents for regulatory compliance
  • Prepares FDA submissions, which may include: 510(k)s, IDEs, IDE Supplements, PMAs, PMA Supplements
  • Prepares Canadian medical device submissions
  • Prepares technical files/design dossiers for European CE mark
  • Interacts with regulatory bodies
  • Reviews and approves promotional material to assure compliance to Regulatory requirements
  • Complies with all Quality System requirements
  • Reviews technical publications, articles and abstracts to stay abreast of regulatory developments in the industry
  • May include other duties as defined by the Regulatory Affairs Manager
  • Excellent writing skills with ability to write detailed information for submissions
  • Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
  • Strong verbal skills including presentation skills
  • Strong interpersonal skills including the ability to interact with all levels of the company
  • Strong computer skills including Microsoft Office
  • Excellent working knowledge of medical device regulations (21CFR) and FDA law
  • Solid working knowledge of the regulatory requirements related to European medical device directives
  • Capacity to communicate regulations to technical functions within the company
  • Ability to manage relationships with FDA
  • Experience with document control systems such as Agile and Oracle
  • Medical device software submission and validation experience highly desirable
  • Minimum of 7+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices
18

Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor's Degree in Pharmacy or Life Science
  • 2-3 years regulatory experience, or combination of higher education/less experience
  • Or substitution of equivalent relevant work experience
  • Broad regulatory affairs experience
  • Good interpersonal skills
  • Good knowledge Global Regulatory Affairs Procedures
  • Proven ability to work effectively in a team
  • A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
  • Familiar with computers and their applications
  • Good organizational and planning skills
  • Must be able to work autonomously with minimal supervision
  • Planning skills
  • Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking
19

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • 8 years of experience, preferably in the medical device industry or related field experience (e.g., hospital / clinical setting, laboratory setting)
  • BA/BS in a Life or Physical Science or equivalent
  • Ability to develop and maintain excellent working relationships with regulatory agencies / bodies
  • Microsoft Office
  • Knowledge of U.S. and European medical device regulations
  • Information Mapping
20

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • 7+ years industry experience in applicable domestic / International submissions, design control systems and/or regulatory compliance
  • 4+ years experience with medical device regulatory submissions
  • Candidate must have a working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions
  • Experience in due-diligence evaluations of companies and/or product acquisitions
  • Experience in marketing materials review and the maintenance of compliant commercialization strategies
  • Experience in electromedical devices
  • Experience with biocompatibility testing and sterilization validation preferred
  • Experience with international medical device consensus standards preferred
  • Good presentation skills
  • Must be able to handle multiple tasks/projects and manage priorities accordingly
  • Have a high tolerance for ambiguity
  • Ability to work in a team environment and exert influence without alienating others
  • Ability to work independently when required with minimal management oversight
  • Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. This position requires a significant amount of initiative and judgment
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers
21

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor's degree in science, engineering, healthcare or related field
  • 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, MHLW, and TGA
  • Knowledge of FDA, EU, MHLW, and TGA requirements
  • Demonstrated experience in preparing PMA or 510(k) submissions for FDA, and Technical Files for EU
  • Demonstrated experience in global regulatory strategy and execution
  • Strong communication and negotiation skills with global regulatory bodies
  • Excellent written and oral communication skills
  • Proficiency in MS Word, Excel, and PowerPoint
  • Excellent organizational and multi-project management skills and attention to detail
  • Experience with Class III devices desirable
22

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Regulatory Affairs Certification (RAC)
  • Experience in developing regulatory strategies
  • Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
  • Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
  • Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results
  • Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
  • Organized, efficient, process-oriented; high attention to detail
  • Effective interpersonal/communication skills
  • Ability to effectively manage multiple projects and priorities
  • Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
23

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Typically responsible for two or more of the following duties
  • Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements
  • Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of medical devices
  • Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk
  • Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products
  • Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations
  • Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance
  • Provide support during government inspections and formulating the appropriate response and corrective actions
  • Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures
  • Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries
  • Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follow-up on CAPAs/observations
  • Stay current with new or potential business opportunities and prepare for all QA Activities
  • Research applicable FDA, ISO standards to ensure the company’s ongoing compliance with the U.S. and International Regulatory requirements (Medical Devices Directives and FDA QS Requirements)
  • Approve packaging/labels for all private label products to assure compliance with regulatory requirements
  • Participate in special projects and perform other duties as required
  • Professional skills with an understanding of industry practices and company policies and procedures
  • Developing proficiency with tools, systems, and procedures
  • Good planning/ organizational skills and techniques
  • Developing problem solving skills
  • Good writing and communication skills
  • Excellent conflict resolution skills
  • Good decision making skills
  • Excellent interpersonal skills
  • Exercise judgment within defined procedures and practices to determine appropriate action
  • Direction from manager/director is needed on some issues
  • SPECIFIC KNOWLEDGE & SKILLS
  • Thorough understanding of regulations applicable to HS operations
  • General Knowledge of ISO 9000
24

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
  • Provide support for acquisitions, including due diligence and post-acquisition assessment and education
  • Provide support for internal and Regulatory Agency audits
25

Regulatory Affairs Specialist Resume Examples & Samples

  • Management of new product development and registration projects and for conducting routine regularoty operations to ensure compliance
  • Provide regulatory support to conduct research trials for new products or label extensions for existing products
  • Assisting R&D and New Product Development Manager as a team member when required product development
  • Provide re-registrations and return/reports for products and ensure that MSD products comply with the regulatory and legal requirements set by the local regulatory authorities
  • Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and MSD Animal Health’s policies and standards, and reflects MSD’s Code of Conduct
  • Support product registrations as required and provide technical support to internal/external customers
26

Regulatory Affairs Specialist Resume Examples & Samples

  • Maintain knowledge of FDA Drug and Medical Device submission requirements. Prepare regulatory submissions assuring that submissions are accurate, submitted on time, and gain approvals as scheduled
  • Specific ability to file New drug applications (NDA) with clinical investigation requirements and abbreviated new drug applications (ANDA)
  • Specific ability to file drug master files for active pharmaceutical ingredients
  • Files supplements and annual reports as required for all active drug and medical device approved and pending applications
  • Evaluates new product proposals presented by customers to assure that the product can be produced in a regulatory compliant manner
  • Maintain organization of regulatory files to assure accurate responses to agency requests and maintenance of medical device design history files
  • Maintain expertise regarding current and developing U.S. and international food, drug, and medical device standards and regulations and how they impact Airgas’s business and quality system
  • Assist in assuring and sustaining compliance with all regulatory requirements associated with medical products and processes
  • Coordinates departmental filing activities for all electronic and paper records associated with FDA and similar activities
  • Review and approve validation protocols and final reports
  • Provide compliance audit and Annual Product Review feedback to business entity leadership
  • Monitor performance against Quality standards and champion suggestions for continuous improvement
  • A Bachelor Degree in Engineering or Life Sciences required
  • 5+ years experience researching, interpreting and maintaining regulatory filings with drug, device and food (FDA) regulations
  • Demonstrated success in management of significant projects in diverse organizations
  • Knowledge of local, state and federal laws pertaining to production of drugs and medical devices
  • Experience resolving regulatory issues in collaboration with agencies and public interest groups
  • Ability to work on global special projects where multiple interests intersect
  • Extremely organized and effective at time management
  • Excellent communication and team leadership skills with strong managerial skills
  • Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Ability to write routine business reports and business correspondence in English
  • Ability to effectively present information and respond to questions from employees and/or customers
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals using the English language
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
  • Ability to compute rate, ratio, and percentages
27

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor Degree in relevant field
  • 7+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs
  • 5+years with Master’s Degree medical device experience, and work experience in regulatory affairs
  • Experience in the preparation of 510(k) submissions, EU technical files and dossiers
  • 10+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs
  • 8+years with Master’s Degree medical device experience, and work experience in regulatory affairs
  • In-depth knowledge of U.S. and EU regulations and a working knowledge of key industry standards applicable to a medical device manufacturer, with functional understanding of international device regulations
  • Direct experience in radiation health regulations
  • Knowledge of Good Manufacturing Practices
  • Basic office computer skills (email, word-processing and spreadsheet software)
  • Must have a high tolerance for ambiguity
  • Must be able to independently identify and initiate tasks/projects in line with objectives
  • Ability to provide guidance to lower level personnel without alienation
  • Regularly addresses complex problem with ingenuity and innovation
  • Ability to handle multiple tasks/projects and manage priorities accordingly
  • Ability to lead a team to completion of objectives
  • Successful track record in working on project teams in a matrix organization environment
  • Experience in the preparation of PMA’s (pre-market approval) and IDE’s (Investigational Device Exemption) beneficial
  • Understanding of diagnostic x-ray products and their respective regulations (21 CFR Subchapter J) preferred
  • Knowledge of international quality and product standards for electro-medical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.) preferred
  • Experience in establishing and implementing world-wide approval strategies for complex capital equipment systems preferred
  • Experience in due-diligence evaluations of companies and/or product acquisitions preferred
28

Senior Regulatory Affairs Specialist for Development Innovations Resume Examples & Samples

  • Working knowledge of current FDA regulations and GCP guidelines regarding regulatory affairs as relating to clinical research
  • High-level of proficiency with MS Office and Adobe Acrobat
  • Exceptional attention to detail in a fast-paced environment
  • Strong organizational and communication skills
  • Critical thinking and good decision-making skills
  • Ability to multi-task and meet strict deadlines
  • 3 - 5 years experience in healthcare, research or other science or research related field
  • 3 years’ experience in regulatory affairs or regulatory operations
  • A degree specific to regulatory affairs or clinical research may be substituted for one year experience in clinical research or regulatory affairs
29

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Analyzes and reports on changes in regulations and their expected impacts
  • Prepares federal and state certification applications and required filings
  • Assists management in the monitoring of state and federal regulatory and legislative development to identify issues affecting company's operations and plans
  • Assists in coordinating the representation of organization's interests before state regulatory and legislative bodies or industry standard setting committees
  • Influences rules and procedures
  • Provides guidance to less experienced regulatory affairs analysts
  • Performs other job-related duties as assigned
  • High School Grad / GED
  • Bachelor's - Arts
  • Experience:7+ years
  • None
30

Audit & Regulatory Affairs Specialist Resume Examples & Samples

  • Assist with coordination of bank-wide regulatory activities, including logistical and administrative support for on-site examinations, coordinating collection/compilation of information requests, scheduling/acquiring necessary resources for examiners (computer access, conference rooms, physical access to buildings, etc.), compiling/drafting letters and other correspondence in response to examination results
  • Maintain effective working relationships with the regulatory examiners and internal management stakeholders
  • Assist with internal communication/dissemination of examination schedules, progress reports, and results
  • Assist with tracking and governance reporting related to regulatory findings and recommendations
  • Work on Internal Audit departmental and cross-functional projects and internal improvement initiatives, as assigned by the Chief Audit Executive or Manager of Professional Practices
  • Perform assigned internal audits, risk assessments, and other reviews
  • Bachelor’s degree in accounting, business, or other related field or equivalent work experience
  • Three to five years of experience in internal audit, compliance, risk management or regulatory affairs required – banking, financial services, or experience in other highly-regulated industry preferred
  • Ability to establish and foster effective relationships and collaborate with internal and external stakeholders at all levels
  • Must have excellent written and verbal communication skills
  • Strong organizational skills required; ability to manage to deadlines, multi-task, and prioritize considered critical for this role
31

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Prepares, review and completes regulatory submissions for INDs, MAAs, CTAs, NDAs, IDEs, ITAs, DSURs and annual reports including post marketing activities to FDA, Health Canada and other regulatory authorities
  • Collaborates with sponsor, study start up, clinical and regulatory staff to ensure that all regulatory documents required for site IP approval are collected and reviewed in a timely fashion
  • Prepares and submits serious adverse events (SAEs) and Safety Reports,Medical Device Report (MDR), Development Safety Update Report (DSUR), Clinical Evaluation Report (CER) Clinical Study Reports (CSR), Unanticipated Adverse Devise Effects Reports (UADEs)
  • Provides update and communicate with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues
  • Assists Associate Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies)
  • Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Identifies essential regulatory documents required for execution of both domestic and global clinical research studies involving drugs, device and combination products
  • Reviews protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
  • Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
  • Provides regulatory guidance and quality assurance assessments for assigned research projects - domestic and international
  • Develops training modules and presentations to ensure compliance with applicable regulatory regulations, CFR, FDA/ICH guidelines, GCP, Essential Regulatory Documents and project specifications
  • Creates SOPs, Work Instructions, and procedures for Regulatory Operations, as needed
  • Serves as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
  • Serves as Novella liaison with central IRBs
  • Serves as a mentor for coworkers and train others on tasks or systems
  • Performs other related duties as assigned
  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
  • Experience interacting with regulatory agencies is preferred
  • Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards
  • Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
  • Ability to read and synthesize technical material and to prepare clear and concise written documents
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance
  • Ability to travel domestically and international
  • Very limited physical effort required to perform normal job duties
32

Regulatory Affairs Specialist Device & Diagnostics Resume Examples & Samples

  • Assist in developing regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits
  • Support preparation of complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, 510(k), PMA, Design Dossier, Technical File, and Canadian Applications
  • Manage assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc., as appropriate to ensure compliance with regulations
  • Primary or secondary regulatory responsibility for assigned projects by providing to the project teams regulatory information, guidance, training, support and strategic planning
  • Keep abreast of, interpret, and communicate applicable regulatory regulations and statutes with internal departments and ensure Novella compliance
  • Participate in business development activities to grow Novella business. Assist in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
  • Perform other related duties as assigned
  • General working knowledge of activities related to medical device and/or IVD regulatory affairs and quality assurance
  • Experience in medical devices and/or IVDs that includes preparation of clinical research and pre- market submissions and registrations
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
  • Ability to read and synthesize technical material and to prepare clear and concise written documents
  • Comprehensive knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Quality Systems Management and Good Laboratory Practices (GLP) requirements
  • Demonstrated experience in client service in the clinical research business preferred
  • Demonstrated high energy level
  • Ability to handle multiple tasks and challenges simultaneously
  • Demonstrated ability to form strong working relationships across functional boundaries
  • Excellent written and verbal communication skills
  • Excellent negotiation skills
  • Ability to develop and manage timelines
  • Ability and willingness to travel
  • Ability to travel internationally
  • Very limited physical effort required to perform normal job duties
33

Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor’s/Master’s degree in a related field preferred, or 6 or more years of hands-on experience with medical device Regulatory Approvals
  • Must have personal experience with preparation and submission of successful 510(k) or PMA submissions and International registrations
  • Minimum of 6-10 years of experience in medical device Regulatory Approvals: US FDA Class II/III, EU MDD, Health Canada, and International registrations
  • Proficient knowledge of medical device regulations: FDA, MDD, global product approval requirements, and standards that are required for product approval
  • RAPs RAC preferred
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions and interface interdepartmentally
  • Proficient computer skills in Microsoft Word and Adobe Acrobat
  • May require 5% travel annually with some international travel possible
34

Regulatory Affairs Specialist Resume Examples & Samples

  • Define global strategies and timelines for regulatory submissions for the total product lifecycle for medical and non-medical software products
  • Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions
  • Identify opportunities to implement process and procedural improvements to drive efficiency within a growing digital health organization
  • Define regulatory responsibilities within a Scaled Agile Framework (SAFe)
  • Communicate and interact directly with regulatory bodies and local health agencies such as US FDA to effectively drive submissions to clearance/approval
  • Provide regulatory guidance to internal product development and IT teams regarding global cybersecurity and software healthcare system requirements
  • Participate as a ResMed representative on external working groups and industry advocacy associations to influence global regulatory policies
  • Creatively reconcile global regulatory requirements for both consumer and medical software products
  • Strategically communicate with global teams to efficiently prioritize and execute regulatory strategies
  • Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System
35

Principal Quality Assurance Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor’s Degree in Engineering, Science or other related fields
  • 5+ years’ experience in a QA/RA function in medical device or pharmaceutical industry
  • Experience with preparation of Technical Files and Design Dossiers in support of CE Marking of new products and maintenance of these documents for existing products
  • Knowledge of global medical devices and combination product regulations (e.g. EU Medical Device Directives/CE Marking, ISO 13485, ISO 14971, ISO 11608, 21 CFR 820, 21 CFR Part 210/211, 21 CFR Part 4, Canadian MDR, JPAL)
  • Demonstrated experience with implementing continuous improvements to medical device quality systems
  • Experience with CE marking of pen injectors, connected devices, mobile medical apps (MMA/SaMD) and infusion pumps
  • Experience with harmonized standards (e.g. EN ISO 10993, EN 60601, EN ISO 14155) utilized to show presumption of conformity with Essential Requirements of EU MDD
  • ASQ Quality Certification or Regulatory Affairs Certification (RAC)
  • Experience with Notified Bodies
  • Six Sigma Black belt experience
  • Demonstrated leadership skills and management experience
  • Demonstrated team player
  • Self-motivated and ability to work without supervision
36

Product Regulatory Affairs Specialist Resume Examples & Samples

  • Lead a team of multiple SDS authors and serve as primary client point of contact for a consumer goods manufacturing company
  • Classify mixtures and pure substances used in consumer products per regulatory requirements using United Nation’s Purple Book
  • Author, update, publish, and review Safety Data Sheets (SDSs) per regulatory requirements
  • Coordinate SDS authoring assignments and progress tracking
  • Position will be primarily be at the client site in Skillman, NJ. Candidate can expect to spend a couple of days per month at our Newtown, PA office. Must be willing to accommodate this local travel to meet with team members
  • 3+ years of directly relevant experience required
  • 8+ years of total professional / non-academic experience required
  • Bachelors degree (BS, BA or BE) can have been obtained in a variety of fields to prepare for a career in product stewardship / regulatory affairs such as: Environmental Science, Environmental Engineering, Chemical Engineering, Chemistry, or other, or equivalent additional relevant work experience
  • Thorough understanding of the United Nation’s Purple Book, OSHA HazCom, and EU CLP regarding classification and safety data sheets (SDSs)
  • Experience classifying mixtures and pure substances and authoring SDS without relying on software rules
  • Familiarity with SDS authority software program(s)
  • Familiarity with consumer goods manufacturing processes and product hazard issues
  • Strong undergraduate coursework in chemistry, including inorganic chemistry, organic chemistry and calculus
  • Previous SDS authoring experience for a consumer goods company preferred
  • Additional experience authoring SDSs for other geographies (e.g., Asia-Pacific, Latin America, Africa) a plus
  • Previous employment with or involving a consumer goods manufacturing company (i.e., pharmaceuticals, household items, cosmetics & personal care companies) preferred
37

Regulatory Affairs Specialist Global Clinical Investigations Resume Examples & Samples

  • Back up activities including item restriction preparation
  • Assisting CSS Global Clinical Regulations Strategy Manager CSS in various internal and external forums as needed
  • Ensures certain administrative tasks to support the CSS EMEA Department
  • Bachelors or Masters degree in an area of science. Clinical study or epidemiology experience preferred (Entry level accepted, 1-3 years regulatory experience preferred)
  • Good written and oral English communication skills
  • Good Computer skills: Outlook, Excel, Power Point
  • Conscientious
38

Regulatory Affairs Specialist Resume Examples & Samples

  • Monitoring, analyzing, and reporting relevant regulatory changes and developments impacting our market and our clients
  • Producing weekly and monthly regulatory reports for both internal EY stakeholders across service lines as well as external committee chairs and boards, ensuring that material aspects of regulatory changes and or developments are highlighted (actual or potential)
  • Proactively managing and maintaining our Stakeholder Engagement plan by organizing meetings for our EY executives, preparing briefing notes and presentations
  • Coordinating and delivering key Regulatory & Public Policy external events from inception to execution
  • Maintaining an up to date and traceable consultation tracker to provide an auditable view on the regulatory consultations identified as relevant to our market, our business and our clients (PMO)
  • Leading on the development of our external R&PP website
  • Previous Regulatory Analyst experience in the UK market
  • Ability to apply an analytical and systematic approach to work
  • Ability to distil complex regulatory issues into simple messages, clearly articulating the ‘so what&#8217
  • Time and project management skills – able to plan and manage time effectively and flex up and down to deal with key priorities
  • Ability to interact well with people at all levels within the firm
  • Excellent oral and written communication skills
39

Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor or Master’s degree in chemistry or life science or relevant discipline
  • 1 - 3 years of experience in a regulatory affairs function in the biopharmaceutical industry
  • Knowledge of FDA/ICH/EU regulatory affairs requirements and guidelines
  • Ability to work on multiple tasks to meet company requirements
  • Demonstrate ability to coordinate and work effectively with cross-functional teams
  • Experience with using an electronic document management system
  • Excellent writing, communication, and interpretive skills
  • Very strong attention to detail
  • Ability to problem-solve independently
  • Ability to manage multiple and diverse issues
  • Good organizational and time management skills; ability to adhere to timelines
40

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Knowledge of Local & International Regulation and Processes
  • Analytical capability
  • Prioritizes work to meet deadlines
  • Communicates clearly, succinctly and effectively
  • Planning and Organizing skills
  • Understands the importance of the adherence to compliance
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Must have 3-4 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record. Desirable experience in Medical Devices, Pharma background is acceptable
41

Temporary Regulatory Affairs Specialist Resume Examples & Samples

  • Perform impact assessments for integration changes and communicate with Integration Contractors at the Business Site
  • Communicate with suppliers and request legalized documentation
  • Request updated Free Sales Certificates
  • Perform local integration change re-registrations, or liaise with local RA contact for that purpose
  • Support the handling and coordination of questions/answers from the local authorities
  • Report the re-registration progress to the Re-registration Roadmap lead
  • University Degree in life sciences, technical (engineering) or related field
  • Experience in medical device EU CE-marking regulations and international regulations is preferred
  • Knowledge in medical devices regulations and regulatory topics
  • Good computer skills, including Microsoft Office Suite
  • Fluency in English both verbal and written
42

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Professional certification(s) preferred
  • Demonstrated success in management of regulatory submissions activities
  • Thorough understanding of global regulations
  • Strong technical knowledge of medical products
  • Strong technical understanding of relevant procedures, practices, and associated medical terminology
  • Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements
  • Thorough knowledge of product development process and design control
  • Excellent research and analytical skills
  • Ability to effectively manage multiple projects
  • Excellent written and oral communication, technical writing and editing skills
  • Strong leadership, interpersonal and influencing skills
43

Product Safety & Regulatory Affairs Specialist Resume Examples & Samples

  • Maintain working knowledge of relevant regulations and ensure transfer and retention of knowledge
  • Provide guidance to assure compliance for AkzoNobel raw materials and products
  • Respond to internal customers and resolve raw material and/or product issues accurately and in a timely fashion
  • Communicate effectively both internally (other departments) and externally (Customers, regulators, suppliers, trade associations)
  • Develop a good understanding of customer needs and relevant regulatory topics affecting the business
  • Be able to translate complex regulatory requirements to practical implications for the business
  • Establishing the impact on Performance Coatings SMUs of legislative changes and support PSRA team leaders in communicating legal requirements
  • Contribute to cross functional project teams as required
  • Producing and updating regulatory roadmaps
  • Manage small internal projects
  • Identify and contribute to the development and continuous improvement of standard procedures (eg SOPs, ISO procedures)
  • Question validity and accuracy of data and seek advice
  • University Degree or equivalent in Scientific discipline
  • Good written and verbal English
  • Good interpersonal skills, working well as part of a team
  • Data manipulation and analysis
  • Ability to understand complex information and make informed decisions based on that information
  • Ability to produce clear and comprehensive reports and make recommendations using the available data
  • Good literacy and numeracy skills
  • Up to 3 years relevant experience (desirable)
  • Background in product regulations, hazard communication and product stewardship (desirable)
  • Experience of working in an industrial environment (desirable)
44

Senior Regulatory Affairs Specialist Device & Diagnostics Resume Examples & Samples

  • Develop regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits
  • Prepare complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, 510(k), PMA, Design Dossier, Technical File, and Canadian Applications
  • Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc., as appropriate to ensure compliance with regulations
  • Primary or secondary regulatory responsibility for assigned projects by providing to the project teams regulatory information, guidance, training, support and strategic planning
  • Keeps abreast of, interprets, and communicates applicable regulatory regulations and statutes with internal departments and ensures Novella compliance
  • Participates in business development activities to grow Novella business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
  • Perform other related duties as assigned
  • Extensive working knowledge of activities related to medical device and/or IVD regulatory affairs and quality assurance
  • Experience in medical devices and/or IVDs that includes preparation of clinical research and pre- market submissions and registrations
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
  • Ability to read and synthesize technical material and to prepare clear and concise written documents
  • Comprehensive knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Quality Systems Management and Good Laboratory Practices (GLP) requirements
  • Demonstrated experience in client service in the clinical research business preferred
  • Demonstrated high energy level
  • Ability to handle multiple tasks and challenges simultaneously
  • Demonstrated ability to form strong working relationships across functional boundaries
  • Excellent written and verbal communication skills
  • Excellent negotiation skills
  • Exceptional ability to conceptualize, develop and manage timelines
  • Ability and willingness to travel
  • Ability to travel internationally
  • Very limited physical effort required to perform normal job duties
45

Regulatory Affairs Specialist Resume Examples & Samples

  • Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  • Travel (approximately 10%) domestic and/or international
  • To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines
  • Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
  • Undertake all required tasks requested to meet departmental and project goals, as appropriate
  • Participate in regulatory and/or clinical trial project teams as required
  • Plan and track designated project activities including financial tracking under supervision
  • Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
  • Prepare and/or write scientific and regulatory documents and communication letters to Regulatory Authorities, either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision
  • Prepare and/or write core regulatory submissions to support clinical trials (Clinical Trial Applications (CTA), Investigational new Drugs (IND), or equivalents), either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision
  • Prepare and/or write regulatory submissions to support post licensing administration/activities, e.g. preparation of variations to product approval either alone or in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of proposed changes under supervision
  • Prepare and/or write elements of regulatory submissions to support marketing authorization applications in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of procedure under supervision
  • Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required
  • Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
  • Keep the relevant Regulatory Project Lead or designee informed of the progress of project activities at all times
  • Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
  • Liaise and work with colleagues from other departments, clients and, Regulatory Authorities as required
  • Maintain an accurate record of the time associated with each activity
  • Other duties as assigned
  • Develop supporting staff skills, encourage growth and provide regular performance feedback
  • Manage designated regulatory project lead projects in accordance with established timelines, budget, quality standards and/or contractual requirements
  • Lead and motivate staff in the projects where assigned as regulatory project lead
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions,
  • Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualification
  • A minimum of 2 years’ experience in regulatory affairs or aligned work and in the pharmaceutical or pharmaceutical contract service industry
  • Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail
  • Good written and verbal communication skills
  • Good written and spoken English
  • Proficient in the use of Microsoft Office
  • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid driver’s license
46

PH Regulatory Affairs Specialist Resume Examples & Samples

  • Handles and supervises product registration administration processes
  • Updates the company on new regulations and procedures
  • Maintenance of corporate databases
  • Clinical Trial Application
47

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Teams with Corporate and International Regulatory staffs to provide support for new products and changes to existing products
  • Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
  • Prepares FDA submissions, Technical Files, Canadian Applications and International Dossiers for new products and product changes
  • Prepares documentation for Clinical Studies and coordinate and maintain study communications
  • Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel
  • Provides support to currently-marketed products as necessary by reviewing labeling, promotional materials, and product and documentation changes per policy and procedure
  • Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management
  • Supports regulatory compliance activities, including manufacturing site registration, GMP, Notified Body audit, post market vigilance reporting, product recalls, etc., as needed
  • Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel
  • Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to management
  • Provides feedback and on-going support to product development teams for regulatory issues and questions
  • Ensures personal understanding of all quality policy/system items that are applicable
  • Performs other related duties and tasks, as required
  • Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines
  • Seven years of regulatory experience, with three of those years of pre and post market clinical trials
  • Must have experience working with the strategic planning and crafting of Class III medical device submissions in the US
  • Experience working with principal investigators, research coordinators, IRBs and ethics committees is preferred
  • Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC) ISO 13485 Quality System Standard and Canadian Medical Device Regulation
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills
  • Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others
  • Demonstrated excellent in submission writing and preparation
  • Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
48

Associate Regulatory Affairs Specialist Resume Examples & Samples

  • Apply the Regulatory Foundation
  • Must be a results-oriented team player capable of working in a fast paced environment with changing priorities
  • Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations
  • Must be organized and detail-oriented, with good analytical and decision making skills
  • Must demonstrate effective verbal and written communications skills
49

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Lead regulatory aspects of the customs, patient-matched and compassionate use programs across Stanmore , UK and Mahwah, NJ teams
  • Develop EU technical documentation/design dossiers to meet the requirements of MDD93/42EEC and support granting the CE mark
  • Interface and coordinate directly with FDA, notified body reviewers, and other regulatory agencies on submissions, approvals or other issues
  • Lead divisional improvement activities and transactional process excellence projects
50

Global Regulatory Affairs Specialist Resume Examples & Samples

  • Ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives
  • Ability to leverage scientific and technical understanding of regulated products to provide input to product lifecycle management and evaluate regulatory impact on products
  • Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations. International regulatory medical device experience is a plus
  • Strong decision making skills in ambiguous or unclear situations
  • Demonstrated attention to detail and organizational skills
  • Capable of effectively managing multiple projects with shifting priorities
  • Ability to identify compliance risks and escalate when necessary
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Bachelor's degree (or country equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Higher degree/PhD will be an advantage
  • Five years or greater of experience in medical device regulatory affairs is preferred
51

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Position provides regulatory support for the Smiths Medical site based in St. Paul, Minnesota. Incumbent develop and prepare regulatory submissions, i.e., 510(k) Premarket Notification, PMA, Design Dossier, and CE Technical Files
  • The Principal Regulatory Affairs Specialist provides the overall regulatory strategy and guidance to project teams and other departments as assigned to ensure achievement of business objectives and government compliance. This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies
  • Develop and prepare regulatory plans, submissions; specifically 510(k) Premarket Notification, PMA, IDE, Design Dossier, Technical Files, Australian Technical Files, Canadian Licensing, and Japan submissions. Coordination of staff support for world-wide registrations for global growth and expansion
  • Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date
  • Participate as regulatory representative on project teams, communicate regulatory requirements and strategy. Prepare and conduct meetings / teleconferences with external regulatory agencies as assigned. Assist with data entry and analysis as needed, ensuring data quality and validity. Ensure compliance with regulatory requirements at all times
  • Support the preparation and maintenance of regulatory submissions as directed
  • 510(k) Premarket Notification, PMA, PMA Supplements, PMA Annual Reports, Design Dossier, Technical Files, Australian Technical Files, Canadian Licenses, and Japan submissions
  • Essential Requirements Checklists, Design Dossiers, Technical Files and Declarations of Conformity for all CE Marked products
  • Communication with government regulatory agencies and Notified Bodies and serve as regulatory liaison on the project team throughout the product lifecycle
  • Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation
  • Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements
  • Support for requests from Corporate Registrations Team for global growth and expansion
  • Maintain all regulatory files, both hard and electronic copies, ensuring documentation, registers, directories and lists are complete and up-to-date
  • Ensure that compliance to standards, pre-clinical and clinical study designs meet regulatory requirements. Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects
  • Review, edit and approve for SMMD label reviews
  • Review, edit and approve operational engineering documentation (through change control)
  • Review, edit and approve project documentation as the active regulatory representative on project teams
  • Support Corporate Registrations Team with Certificate to Foreign Government applications
  • Participate as Regulatory Representative on project teams
  • Review, edit and provide internal regulatory approval signature for project documentation as the active regulatory representative on project teams
  • Monitor project time-lines and assist in coordination of timely regulatory processes, documentation
  • In collaboration with senior regulatory representative, prepare and communicate project regulatory strategy
  • Review and ensure regulatory compliance of internal operational and project documentation and all applicable technical standards involved in product development and commercial product release for all assigned projects
  • Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date
  • Develop regulatory plans and departmental positioning in collaboration with the Manager and Director of Regulatory Affairs and Design Assurance
  • Participate as regulatory representative on project teams, communicate regulatory requirements and strategy
  • Prepare and conduct meetings/teleconferences with external regulatory agencies as directed
  • Ensure compliance with regulatory requirements at all times
  • Review of device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend appropriate changes
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001,MDD 93/42/EEC and government occupational health and environmental regulations and statutes
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
  • The Manager and/or Director of Regulatory Affairs may assign other duties, i.e., training, documentation, etc
  • Manage multiple simultaneous global projects with cross functional teams
  • Mentorship and development of junior regulatory staff and training for cross functional partners
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Participate as Regulatory Representative on project teams
  • Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Ten to twelve years direct experience in regulatory affairs in the medical device/drug or biomedical area
  • RAPS Professional Certification (RAC) required
  • Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology
  • Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team
  • Excellent leadership, interpersonal and influencing skills
  • Ability to manage multiple projects and proficiency with Microsoft Office and software tools. Ability to manage multiple projects and proficiency with Microsoft Office and software tools
  • Ability to analytically assimilate regulatory information and updates and effectively convey these principles to appropriate cross functional departments and levels of management
  • Ability to critically analyze information as it relates to regulatory submissions and clinical protocols
  • Excellent verbal, written, and presentation communication skills
52

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
  • This includes pre-award activities, oversight of the scope of work, budget and resources
  • Developing and implementing the RSU Management Plan
  • Ensuring collaboration across RSU, including communication with regions and countries
  • Assisting with the creation and review of core scientific, technical and administrative documentation
  • Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
  • Ensuring overall project efficiency and adherence to project timelines and financial goals
53

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor’s degree with 7 years of work experience or Master’s degree with 5 years of work experience
  • Experience in a Regulatory function/role
  • Experience in developing and preparing regulatory submissions (i.e. Premarket Approval (PMA) for Class II and/or Class III medical devices
54

Senior Quality Assurance & Regulatory Affairs Specialist Resume Examples & Samples

  • Initiate and carry out QA&RA activities for assigned products throughout the product lifecycle, collaborating with project managers, R&D teams and external agencies as applicable
  • Monitor, investigate, document and advise on relevant regulatory requirements and standards
  • Liaise with selected standards agencies, testing labs and regulatory authorities to ensure timely completion of regulatory activities, provision and filing of evidence of compliance, and resolution of compliance issues
  • Establish standard operating procedures and work instructions as required for QA&RA and cross functional activities; conduct review and approval of those activities and maintain records according to good documentation practices
  • Review and approve deliverables from other parties, internally and externally
  • Participate in risk management, vigilance and post-market surveillance for medical device products
  • Implement and maintain the Ascom Management System within the North American region, including maintenance of the Site Quality Plan
  • Coordinate, train and support regional staff on quality & regulatory matters
  • Investigate customer complaints, observations, non-conformities and reported quality and regulatory issues
  • Initiate and drive cross-functional improvements to increase customer satisfaction, compliance and quality
  • Maintain effective Document Control procedures in the region, and act as local super user of SharePoint
  • Plan, prepare, coordinate, host/conduct, report and follow-up regional external and internal quality, audits in accordance with global audit program
  • Initiate, drive, document, follow up and ensure timely closure of CAPA
  • Report on quality system effectiveness and requirements to the management team as required including preparing and executing Management Reviews for the region
  • Bachelor's degree, or equivalent, in Engineering, Science, Healthcare, Business Administration, Political Science or Law, or corresponding academic merits
  • Five years’ relevant working experience within healthcare, ICT or other technology businesses, whereof two years’ experience of quality assurance, regulatory affairs, R&D, clinical affairs or other regulated activities
55

Associate Regulatory Affairs Specialist Resume Examples & Samples

  • Job title: Associate Regulatory Affairs Specialist
  • Reporting to: Regulatory Affairs Manager
  • Functional group: Market Access
  • Ensures compliance with regulatory agency regulations and interpretations
  • Prepares responses to regulatory agencies' questions and other correspondence
  • Organizes and maintains reporting schedules for new drug application and investigational new drug
  • Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Provides solutions to a variety of problems of moderate scope of complexity
  • Conducts searches of existing files for requested information
  • Maintains and archives all regulatory documentation
  • Bachelor Degree or above
  • Minimum 2 years solid and reputable experience in regulatory affairs
  • Proficiency in both spoken and written English and Chinese
  • Essential –
  • Market Knowledge
  • Business Relationship
  • Regulatory Environment
  • Reimbursement
  • Important –
  • Ability to manage multiple projects1700171754W
56

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Demonstrate and deliver on the Regulatory & Scientific Affairs Department (RSA) Strategic Roles
  • 5+ years experience in the food industry, primarily in regulatory affairs, regulatory compliance, nutrition or product development
  • Must be a results-oriented team player capable of working in a fast paced environment with changing priorities
  • Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations
  • Must be organized and detail-oriented, with strong analytical and decision making skills
  • Must demonstrate strong verbal and written communications skills, along with strong influencing and negotiation skills, recognized expertise in functional area, and a strong ability to communicate regulatory and technical issues in lay terms
  • Must demonstrate strong interpersonal and influencing skills, and be able to act in an appropriate role depending on the situation - facilitator, contributor, leader, executor, etc
  • Must be proficient in Windows-based applications – Word, Excel, PowerPoint, Access (preferred)
57

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Primary responsibilities will be to provide regulatory affairs input requirements to design and development teams
  • Prepare and/ or review regulatory strategies, risk management files, applicable codes and standards, regulatory aspects of design projects
  • Conduct risk and usability assessment of new product designs
  • Prepare information and submittal documentation to support S&N in-country RA teams for product submittals and registration maintenance
  • Represent Robotics RA on S&N Corporate teams relating to new MDR implementation and OUS UDI implementation
  • Prepare or aid in preparation of domestic regulatory submittals
  • Other duties as assigned
  • 10 years’ experience with International, U.S. FDA 510k submittals and IDE submissions
  • Successful interaction with international regulatory agencies (MHRA, PMDA, TGA, etc.) and FDA reviewers required
  • Working knowledge of the EU CE marking process including requirements for a MDD/MDR technical file
  • Working knowledge of ISO 14971 Risk Management principals and ISO 62366, Application of Usability Engineering to Medical Devices
  • Recent experience in ISO 13485, Medical Device Quality Systems
  • Strong leadership, interpersonal, communication and organizational skills required
  • Must possess a high level of critical and strategic thinking skills and be a detail-oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities
  • Knowledge and experience in development of electromechanical medical devices a plus
58

Associate Regulatory Affairs Specialist Mena Resume Examples & Samples

  • Prepares and coordinates regulatory/registration submissions
  • Obtains timely regulatory approvals to meet business objectives
  • Ensures that submissions meet relevant external and internal requirements
  • When/where applicable supports distributors to obtain the necessary regulatory approvals and other regulatory requirements
  • Liaise and ensure effective communication and coordination with all needed stakeholders (SBU, business distributor etc..)
  • Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization
  • Provides support to tender and importation requests in case of necessary regulatory documentation
  • Follow up on Quality Requests, as assigned by the Regulatory Affairs Manager
  • Ensure full alignment in all activities with relevant department process and company SOP (i.e. order releases, documentation, etc.)
  • Track and report regulatory project status and informational documents appropriately
  • Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance. Ensure that existing approvals and documentation are maintained as per department/company and region requirements
  • Coordinate, monitor and execute of Regulatory PMS activities including Vigilance reporting and Field Action within the ME region when applicable and as assigned
  • Work in accordance with Work Instructions, monitor and record related documentation
  • Provide additional support for the RA department as needed
  • Ensure Regulatory and Quality compliance for the region through appropriate documentation and filing in respect to RA and Quality regional activities and documents
  • University degree in Business Administration or Science
  • Fluency in oral and written English. French is plus
  • 1 - 2 years of administrative experience
  • Computer literate
59

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products
  • Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
  • Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release
  • Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
  • Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams
  • Provide feedback and on-going support to product development teams for regulatory issues and questions
  • Ensure personal understanding of all quality policy/system items that are personally applicable
  • Follow all work/quality procedures to ensure quality system compliance and high quality work
  • Bachelor’s degree in an engineering or scientific discipline
  • 7+ years with Bachelor’s degree and work experience in medical device regulatory affairs
  • 5+ years with engineering degree or advanced degree and medical device work experience
  • Engineering degree
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
  • Experience in the preparation of 510(k) submissions for FDA and Technical Files for EU
  • Experience with international standards (ISO, GHTF, ICH)
  • Experience in medical device acquisition due diligence
  • Proficient computer skills (email, word-processing and spreadsheet software)
  • Effective cross-functional team player
60

Principal Regulatory Affairs Specialist Resume Examples & Samples

  • Prepare worldwide submissions for new products required to ensure timely approval for market release, product changes or clinical studies
  • Develop worldwide regulatory strategies/plans and lead implementation. Provide on-going expertise to teams for regulatory issues and questions
  • Provide comprehensive product information to worldwide peers for product introductions and training. Review advertising, promotion and training materials. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and determination of change on existing submissions and creation of submissions for changes requiring government or notified body approval
  • Negotiate directly with the FDA or notified body on all projects and/or products as needed. All significant issues will be reviewed by the manager
  • Regularly communicates with senior management and regulatory agencies. Influence and inspire alignment with business goals, internally and externally
  • Apply extensive technical or regulatory principles, theories and concepts and has full knowledge of other related disciplines
  • Develop strategies that leverage opportunities and experiences across functions
  • Develop technical solutions to complex problems that require the regular use of ingenuity and creativity. Play a leadership role in resolving conflicting and ambiguous inputs
  • Keeps current on global directives, harmonized standards and procedures and communicates changes to the business that may affect cross functional areas
  • Maintain Regulatory Affairs product files to support compliance with regulatory requirements
  • Participate in external and internal audits for compliance to regulations and harmonized standards, resolve audit findings, as needed
  • Provide training and support to other members of the department
  • Other tasks, as required
  • BA/BS/MS/Law degree
  • 5 years or more of experience in regulatory affairs or FDA experience
  • Experience with internet/intranet technology and interactive software applications
  • Competency with Microsoft Office applications and Adobe Acrobat
  • Seasoned professional with significant experience with FDA requirements, guidance documents, 510(k) submissions, EU Medical Device Directive/Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
  • History of successful global device submissions
  • Through knowledge of GCP/GLP requirements
  • Recognized expertise in one or more areas of regulatory
  • Significant knowledge of other cross functions and business acumen. Expert problem solving skills and experience with complex issues that require resolution. Ability to work independently and make decisions that have significant impact to the company. Experience with interacting and building relationships with regulatory agencies
  • Knowledge of clinical study requirements
  • Excellent negotiation skills and written/oral communication skills
  • Demonstrated organizational , time management, and project management skills
  • Self-motivated. Acts on own initiative to identify opportunities and propose solutions outside the scope of their job responsibility
61

Associate Regulatory Affairs Specialist Resume Examples & Samples

  • Bachelor’s degree in scientific or engineering discipline
  • Proficient with MS Office software
  • Demonstrated technical writing skills
62

Senior Regulatory Affairs Specialist Resume Examples & Samples

  • Class II (or III) medical device (US) registration experience and US FDA experience required
  • European Union (EU) Class IIb/III medical device registration experience a plus
  • Regulatory experience in Asia a plus
  • Project management experience a plus
  • RAC-US certification desired
  • Experience in biologics a plus
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and in writing
  • In depth knowledge of U.S. and/or international medical device regulations and standards
  • Extensive knowledge of and ability to prepare regulatory documentation
  • Proven effective leadership and team skills. Strong interpersonal skills
  • Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions
  • Analytical and creative thinking skills and the ability to solve complex problems
  • Or-