Regulatory Program Manager Resume Samples
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Regulatory Program Manager Resume Samples
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MF
M Funk
Myriam
Funk
66497 Sage Glens
Dallas
TX
+1 (555) 361 0662
66497 Sage Glens
Dallas
TX
Phone
p
+1 (555) 361 0662
Experience
Experience
Chicago, IL
Regulatory Program Manager
Chicago, IL
Zulauf Group
Chicago, IL
Regulatory Program Manager
- This is a great opportunity for a programme manager to join a high-performing and successful development group within a leading, global Investment Bank
- Provide leadership and program management for projects as directed by manager
- Establish and provide tactical alignment across PCMS on regulatory aspects of
- Liaise with Project Managers, Development Leads and Business Analysts to plan, track and deliver large regulatory programmes
- Working on a portfolio of projects with critical deadlines and as part of a global team
- Manage Governance and stakeholder reporting to broad range of senior stakeholders across the organisation
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards
Los Angeles, CA
Regulatory Operational Excellence Program Manager
Los Angeles, CA
Little and Sons
Los Angeles, CA
Regulatory Operational Excellence Program Manager
- The primary responsibility of this role, as Regulatory Affairs Operational Excellence Project Manager is: To ensure the development and implementation of strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
- To help ensure the development and implementation of various strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Global Regulatory Affairs Organization
- To ensure that the Regulatory Affairs processes for medical devices across Bayer Medical Care are harmonized, standardized, and optimally implemented
- To ensure the definition, development, and implementation of best in class Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
- To be responsible for creating GRA MC action teams to support BHC and BMC continuous process improvement initiatives
- To be responsible for leading cross-functional teams
- To ensure the continuous assessment of process workflows to maximize efficiencies
present
Houston, TX
Global Regulatory Reporting Controls Oversight Transaction Review Program Manager
Houston, TX
Schroeder, Hudson and McKenzie
present
Houston, TX
Global Regulatory Reporting Controls Oversight Transaction Review Program Manager
present
- Responsibilities of Transaction Review Project Manager include
- Project management and status reporting
- Perform US Team and FAKC team coordination
- Oversee the end-to-end data quality review process, including scope development, sampling, transaction testing, and communication of observations for assigned area of banking product focus (Wholesale Banking, Mortgage Lending, Consumer Lending, Trading Products)
- Coordinate with central CCAR Project Management Office to ensure accurate reporting of progress, status, and risks
- Oversee the progress, status, and risks across all activities for end-to-end components in the testing program (prioritization, sampling, testing, observations / issues)
- Coordinate with Centralized Regulatory Reporting (CRR), Front Line Units (FLUs), and data providers to verify the sampling approach
Education
Education
Bachelor’s Degree in Healthcare Related Field
Bachelor’s Degree in Healthcare Related Field
University of Oregon
Bachelor’s Degree in Healthcare Related Field
Skills
Skills
- Philips PCMS experience highly desired
- Proficient computer skills in Microsoft Office
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards
- Ability to manage and influence senior stakeholders
- Ability to work with disparate development teams using both waterfall and agile methodologies
- Strong background in Design Controls
- LI-Recruiter
- Experience in supporting international registrations and/or clinical investigations
- LI-Priority
- Understand LEAN concepts, methodologies and deployment
15 Regulatory Program Manager resume templates
Read our complete resume writing guides
1
Global Regulatory Program Manager Resume Examples & Samples
- Bachelor's Degree in the Sciences
- Knowledge of FDA regulations
- Able to work effectively in a matrix team environment
- 5+ years of experience in regulatory affairs
- Pharm D
2
Regulatory Program Manager Resume Examples & Samples
- The scope of the team is global and wide ranging, which reflects the regulatory portfolio of a large global business, and hence the depth and knowledge of the regulatory landscape, as well as, understanding of the impact to an asset management firm is critical
- Focus on regulatory management and implementation. Your knowledge and subject expertise will be used to assist the business with implementation of many regulatory initiatives
- This challenging role requires working very independently with a very pragmatic and hands-on work approach
- Working on a portfolio of projects with critical deadlines and as part of a global team
- Engagement with internal stakeholders and external industry regulatory experts
- Proven track record of management complex projects from impact assessment through to implementation, including planning, as well as, execution
- Strong communication skills are required, complimented by a convincing and persistent personality in order to be successful in this role
- You will be a highly organised, proactive and credible professional that is able to work efficiently and effectively under project deadlines
- University degree and/or equivalent work experience
3
Regulatory Interaction & Examination Senior Program Manager Resume Examples & Samples
- Support the definition and communication strategies for regulatory exam management in order to meet Citi’s legal, regulatory and compliance requirements
- Support the regulatory examination process as a lead contact/central point of communication with regulators for examinations and requests – schedule, objectives, etc. – and provide status updates to O&T Senior Management on periodic basis
- Drive the collection, review and management of deliverables required for successful completion of Regulatory examinations and ongoing requests
- Coordinate, develop and review regulatory examinations draft responses
- Support the quality assurance process of evidentiary materials in support of issue closure
- Support the coordination of O&T level communications and engagement with Audit Workgroup
- 7 - 10 years experience working in operations and technology risk and / or control functions within a financial services organization
- 3- 5 years experience working with external regulators within a financial services organization
- Effective leadership skills
- Strong written and oral communications skills, including presentation skills
- Able to communicate effectively at all levels of the organization
- Individual should be analytical, flexible, team-oriented, have good interpersonal and follow up skills with strong attention to detail and ability to multi-task
- 4 year College Degree, or equivalent experience
4
Regulatory Interaction & Examination Senior Program Manager Resume Examples & Samples
- Support the regulatory examination process as a lead or support contact/central point of communication with regulators for examinations and requests – schedule, objectives, etc. – and provide status updates to IS Senior Management on periodic basis
- Collect, review and manage deliverables required for successful completion of Regulatory examinations and requests
- Analyze regulatory requirements and help define and/or validate the controls that address the requirements
- Utilize strong analytical skills to evaluate controls, identify control issues, review project plans and corrective actions to identify missing milestones and tasks
- 7 – 10 years experience working in technology risk and / or control functions within a financial services organization
- Technical expertise/acumen of distributed, network and mainframe platforms/environments
- Experience in managing global or cross-business projects in a matrix organizational structure is required
- Demonstrated leadership and adaptability when facing unique challenges of a dynamic organization
- Strong interpersonal skills, including the ability to partner with others and deal effectively with multiple projects and changing priorities
- Excellent influencing and negotiation skills and ability to work effectively with all levels of the organization as well as geographically disbursed teams
- Able to take ideas from concept to execution
- Proven ability to work independently in a fast paced multi-tasking environment
- Technical proficiencies in MS Word, Excel, PowerPoint and Visio
5
Regulatory Program Manager Resume Examples & Samples
- Product Control RPL central representative and primary contact point in regulatory related matters
- Oversee and direct changes to the methodology and logic utilized in supporting Regulatory compliance
- Monitor changes in the regulatory environment and make appropriate plans to ensure Product Control’s compliance
- Identify and coordinate the execution of process standardization initiatives across Product Control RPL and oversee ongoing compliance thereon
- Develop and present material to various stakeholders to enhance regulatory comprehension and help drive better business decisions
- 8-10 years experience in financial services, preferably in Product Control, having undertaken Regulatory program related roles within complex cash & derivatives areas
- Product Control / Risk experience, ideally within cash and derivatives (OTC & Listed)
- Experience in regulatory driven programs, Basel III, IHC and Volcker preferred
- Excellent Presentation skills, proven proficiency in PowerPoint
- Proven track record of program management and delivery
- Understanding of the P&L and balance sheet process in a trading environment
6
Privacy & Regulatory Program Manager Resume Examples & Samples
- Help to coordinate Facebook's global privacy program framework for the legal department
- Work on projects related to ongoing compliance with data protection and privacy laws, and related requirements, including in particular ongoing maintenance and improvement of our internal privacy program
- Document Facebook's global legal obligations, including commitments to the Irish Data Protection Office and the US Federal Trade Commission
- Coordinate regular and comprehensive audits of our systems and procedures, which are then audited by independent accounting firms
- Assist in the development and deployment of trainings that highlight rules and regulations that companies must adhere to successfully meet legal requirements
- B.A. or B.S. degree or equivalent with 8 or more years of experience in Privacy, preferably within a legal environment, consulting firm or prior in-house experience with internet or technology companies
- Candidates must be very flexible and willing to work on projects in other areas
- Demonstrated ability to work in fast-paced environment and under tight deadlines
- Demonstrated ability to advance large, complex projects as a project manager
- Talent for thinking creatively in confronting new issues and pursuing novel approaches to old problems
- Strong knowledge of and interest in emerging technologies and devices and of Facebook products and platform if preferred
- Privacy certification (e.g. CIPP or CIPM or similar) is preferred
- Excellent academic credentials
7
Program Manager, Quality & Regulatory Build Resume Examples & Samples
- Experience with build and architecture of Electronic Health Record (EHR) in care delivery, preferably Epic
- Minimum of 3 years of project management experience and project oversight, preferably with one or more EHR
- Demonstrated ability to identify, design and implement process improvement, as evidenced by achieved and
- Knowledge of primary and specialty care and large-scale deployment techniques
8
Privacy & Legal / Regulatory Program Manager Resume Examples & Samples
- Partner with stakeholders throughout CCB including Digital’s Control Partners - Legal, Compliance, Risk, and Controls for Legal/Regulatory Procedures, Action Plans, RCSA and other Privacy tasks for sustainability
- Assist in the establishment and implementation of effective Privacy, Data Management, Information Owner practices within Digital including coordination with the Global Privacy Office
- Facilitate and track Digital Privacy and Legal/Regulatory Procedure reviews
- Record Retention - recertification of non SEAL, CC validation and impact assessments if Global changes mandated (i.e. legal requirement to change retention)
- Digital Retention Purge – coordinate overall Privacy office reviews and actions based on purge processes (i.e. if profile rules change)
- Facilitate and gather Audit evidence as needed
- Be available to support the respective Privacy and Legal/Regulatory Compliance Lead and participate in workgroups, strategic projects or targeted reviews that require business engagement
- Drive the implementation of LOB Privacy and Legal/Regulatory procedures and ensure that such procedures are maintained, accurately and comply with applicable policies and requirements
- Assist the business with the design and execution of controls to address privacy business requirements and mitigate privacy risks
- Assess the impact of Legal and Regulatory changes (Privacy, UDAAP, etc) on the business & technology operations, processes or procedures, including modifications needed. Provide transparency to Compliance, Controls, Risk, Legal Leads into the LOB preparedness for complying with regulatory change
- Assist and facilitate the business with preparing for Legal/Regulatory related exams, compliance tests and internal audits and notify and engage Compliance, Control Leads during such reviews
- Manage assigned Legal/Regulatory issues in FORCE or other system of record; escalate risks to management and to Control Partners. Where appropriate take ownership for actions in FORCE with respect to areas such as execution of controls
- Work within the business to ensure that privacy incidents are reported timely and accurately to the Privacy Incident Response Lead, in accordance with policy; assist LOB in determining necessary client notifications as appropriate
- Manage the local college internship program which involves working with local colleges in the interviewing, hiring, onboarding and coaching of interns
- Excellent oral, written, and presentation communication skills
- 8+ years experience in related role
- BS/BA in Business, Computer Science or related field
- Must be extremely organized, detail-oriented and capable of self-managing and multi-tasking in a fast-paced, demanding environment
- Self-starter with excellent time management and problem-solving skills
- Exceptional interpersonal skills with proven experience in relationship building, influencing and partnering
- Ability to work independently and in groups including global matrix managed organizations
- A solid understanding and comfort level with MS Office including, Excel, Word, PowerPoint, Project and Share Point is required
- Experience in implementing legal and/or compliance requirements into business practices (processes & procedures) and conducting privacy, operational and/or technology risk assessments
- Understanding of processes and information flows for business and operational units that manage customer, employee data and other confidential information
- Relevant experience working with support functions such as operations, controls, marketing, preference collection, information management, information technology, and third party management. Privacy operations experience a plus
9
Regulatory Operational Excellence Program Manager Resume Examples & Samples
- The primary responsibility of this role, as Regulatory Affairs Operational Excellence Project Manager is: To ensure the development and implementation of strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
- To help ensure the development and implementation of various strategic operational objectives for Radiology Regulatory Affairs that drive the creation and maintenance of an aligned “best in class” Global Regulatory Affairs Organization
- To ensure that the Regulatory Affairs processes for medical devices across Bayer Medical Care are harmonized, standardized, and optimally implemented
- To ensure the definition, development, and implementation of best in class Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
- To be responsible for creating GRA MC action teams to support BHC and BMC continuous process improvement initiatives
- To be responsible for leading cross-functional teams
- To ensure the continuous assessment of process workflows to maximize efficiencies
- To ensure the development of effective regulatory processes that support competitive labeling
- To ensure the creation and implementation of global regulatory processes that render comprehensive regulatory plans, assessments, and strategies that are based on the effective interpretation of current global regulatory requirements
- To create processes that effectively monitor global regulatory environments and anticipate changes in regulations, guidelines, etc. that may affect the clearance/approval of new devices & drugs or current marketed devices & drugs
- To foster team spirit and cooperation within GRA, across the different functions of MC Innovation/CMO, and other BHC divisional GRA organizations
- To ensure the development and implementation of strategic operational objectives for Global Regulatory Affairs Medical Care that drive the creation and maintenance of an aligned “best in class” Regulatory Affairs Organization
- To ensure that the Regulatory Affairs processes for medical devices across Bayer HealthCare are harmonized, standardized, and optimally implemented
- To ensure the definition, development, and implementation of “best in class” Regulatory Affairs processes, applied technologies, and regulatory quality standards; with a focus on medical devices and combination products
- To help create and lead cross-functional teams to support BHC continuous process improvement initiatives
- To continuously assess process workflows and assist in the development of optimization tools to maximize efficiencies where possible
- Bachelor's degree from a four-year college or university required
- Minimum of 5-9 years of experience in the healthcare industry including Regulatory Affairs
- Strong domain knowledge of global medical devices
- Strong domain knowledge of global medical device requirements
- Strong domain knowledge of global medical device quality standards and compliance requirements
- Strong domain knowledge of design controls for medical devices
- Strong understanding of the working of global regulatory agencies
- Strong analytical, problem solving, and strategic skills with good business acumen
- Strong networking abilities
- Used to interacting with and leading international and multicultural teams
- Possess an understanding of marketing of medical devices
- Project team environment experience
- Proven track record in people/team building skills
- Must be motivated to work independently as well as with cross-functional teams
- Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., Regulatory agencies
- Self-starter with a proactive and energetic attitude
- Solid communication skills in English and ability to communicate in regional language is also desired
10
Program Manager, Commercial Regulatory Resume Examples & Samples
- Technical and Business Expertise – Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area
- Teamwork and Collaboration – Addresses and resolves conflict by creating an atmosphere of openness and trust. Establishes strong collaborative relationships. Inspires others to do their best work by offering support and encouragement
- Achieving Results- Is goal-directed, persistent, driven to achieve objectives. Holds self accountable for meeting commitments. Recognizes the contributions of teammates and peers
11
Regulatory Intelligence Program Manager Resume Examples & Samples
- Maintain existing EHS policies, processes, and guidelines. Develop new EHS policies, processes, and guidelines as required by regulatory changes and new business growth
- Manage the EHS regulatory contacts process, including tracking, investigating and responding to contacts
- Monitor emerging EHS regulations or interpretations and determine any that may have impact on the business. Communicate, partner and educate with necessary
- Analyze EHS regulatory contacts to discover trends to justify the allocation of appropriate resources or program modifications to areas where risk is highest
- Possess a detailed understanding of applicable legal requirements (i.e.: Codes, Standards, and Administrative Policies) and provide technical expertise, regulatory knowledge, and Amazon EHS policies
- Provide program technical and administrative support in areas such as design-in-safety, risk assessment, job safety analysis, investigation and resolution, development and programming of EHS systems, and integrating EHS practices into operations processes
- Provide technical capability to the EHS and engineering activities as they develop processes and procedures
- Assist in the development of related processes and/or the integration of EHS elements into current processes
- Provide ‘single-point of contact’ to the EHS team for understanding existing EHS regulations and regulatory activity (compliance of new technologies with applicable codes and standards)
- Function as technical resource for FC and regional EHS staff
- Serve as technical resource to the engineering team
- Develop onboarding process and training materials designed specifically for EHS team members
- Responsible for management and benchmarking best practices internal & external to North America
- Through Six Sigma/Lean methodologies, partner with Operations and Engineering in reducing risks and injuries
- Support the generation of the annual operating plans (OP1&2), Whistle Stops, Peak Plans, etc. and standardize tools used across NAFCs
- A completed Bachelor’s Degree in industrial safety or other engineering discipline from an accredited university or 2+ years Amazon experience
- 3+ years’ experience serving as an EHS technical resource or program manager
- Experience analyzing and interpreting data
- Experience solving large scale, cross-functional EHS problems in a manufacturing of distribution center environment
- Strong attention to details and ability to multi-task multiple urgent issues at once
- Should possess or be working towards recognized professional certification
- Excellent written and verbal communication skills, including comfort interfacing with the FCs safety and leadership teams
- Experience in a fast paced, changing/growing organization is a plus
- Experience demonstrating a high level of interpersonal skills to work effectively with others
- Legal background (paralegal or otherwise)
12
Global Consumer Bank Cborc Tax Regulatory Program Manager Resume Examples & Samples
- Leadership and oversight over the day to day program management of 4 key project workstreams: Foreign Account Tax Compliance Act (FATCA), The Common Reporting Standard (CRS), 871(m) and Tax Transparency
- Ownership of all senior management materials including senior management project updates, senior management proposals on approach, etc
- Ownership of the Tax Regulatory Operating Committee and Senior Management Update meeting agenda, materials and organization
- Drive process and procedure review across all countries to develop standardization and best practices in meeting compliance requirements
- Lead efforts to escalate and develop mitigation/remediation plans against issues and/or risks identified across any of the projects
- Coordination of requests from senior management on an ad-hoc basis
- Maintain effective communications to all stakeholders, ensuring team interaction model is transparent and effective
- Oversight of new project plan creation or updates to project plans, distribution and review for all GCB countries. This occurs at least every 6 months, and sometimes quarterly based on program needs
- Defines strategy and plan for program communications and oversees the coordination of any global level communications that are distributed to all GCB employees
- Strong knowledge and proven adherence to the Citi Project Management Policy (CPMC)
- Bachelor's Degree required; MBA/MS preferred
- Strong interpersonal, influencing and written/verbal communication skills
- Forward thinker with independence of thought
- Proven capability to adapt in a face passed, evolving work environment
13
Product Safety & Regulatory Program Manager Resume Examples & Samples
- The Product Safety and Regulatory (PS & Reg) Leapfrog program manager ensures that the “Leapfrog” program (~8 projects) is managed in a coordinated way
- The program manager is accountable for program delivery through design phase until successful implementation in this multi-year transformation up until end of 2019
- Own the Leapfrog master plan for all related initiatives and ensure that it remains cohesive and in line with overall vision and blueprint for PS & Reg
- Provide transparency and clarity on program plans and progress to enable informed decision making by senior stakeholders
- This role will be accountable for communicating escalated risks for review & mitigation, also for reporting, in agreed upon format for consolidation & review by the relevant governance and steering committees
- This role, will coordinate closely with the Program senior responsible owner (SRO) and business change managers (BCM) & global business process owners (GBPO) to ensure that all related projects globally and within the region will be delivered
- Ensure that Syngenta’s program and project management methodologies (MSP, BCM) are followed, including proposed stage gate advancement approach, status reporting, issues and risk management
- Deliver transparency regarding cross project / program interdependencies, with emphasis on understanding impact of projects on the regional population, working with respective project teams to improve coordination and mitigate related risk
- This role will also liaise as required with others to engage with stakeholders in all regions and partnering functions and leadership teams to successfully deliver the leapfrog program
- People leadership of directly 9 and indirectly 3 ( Manage 6 Project managers and PMO team of 3 as well as indirectly the change and comms team ~3FTE))
- Manage external provider who deliver services to the program (consultancies, implementation partner, IS vendors,…)
- Collaborating with the various project managers and business owners to ensure that the timing and content of planned program deliverables are feasible
- Undertaking qualitative reviews as required on mandatory project support documents
- Challenging & validating that required program governance framework is adhered to
- Providing guidance and support to project teams, on any and all related project issues, including training on proposed project governance & related methodologies
- Day-to-day management of the program from ‘design’ to ‘closure’
- Planning and designing the program and proactively monitoring its overall progress, reporting the progress at regular intervals
- Managing and resolving risks and issues
- Ensuring key documents are created and updated as necessary, such as the Blueprint and Benefits Map And Benefit Profiles
- Defining the program governance framework
- Monitoring the program budget and the expenditures and costs against benefits that are realized as the program progresses
- Collaborating with the business leads to ensure that the timing and content of planned program deliverables are feasible in the relevant business areas
- Managing the communications with stakeholders by initiating activities and interventions as needed
- Engaging up to SEC level with funding submissions and progress presentations
14
Global Regulatory Relations Group Central Team Operations & Program Manager Resume Examples & Samples
- Provide support to the Global Head of GRRG in continuing to build out and centralize the GRRG operational framework
- Coordinate organizational and administrative matters, such as annual budget, organizational charts, and GRRG Business Continuity Planning
- Communicate and coordinate regularly with regional Regulatory Relations Group (RRG) teams, including regarding status of exams, findings and reporting
- Review RRG reporting and external regulatory and industry news to identify key supervisory developments and trends; synthesize into global reports for the Firm’s senior executives and stakeholders
- Assist in producing and preparing agendas and materials for management meetings between the Global Head and RRG Heads or other Firm staff and regulatory or other external meetings, as appropriate
- Develop and prepare reporting and metrics from the OpenPages assessment management tool (GRAMS) for the Global Head and Central Team
- Manage special initiatives and ad hoc projects, as appropriate
- Assist with development of the GRRG Annual/Strategic Plan and tracking of progress to plan
- Coordinate and produce global training efforts
- Contribute to annual or periodic updates to policies and procedures
- Maintain the GRRG LCD Portal InfoPage
- Participate in Divisional or Firm-wide initiatives/projects on behalf of GRRG, as appropriate (e.g., Firm Recovery/Resolution Communications Plan; Annual Operational Mapping Exercise)
- 4+ years of in-house compliance or legal, law firm or government regulatory experience
- Highly motivated self-starter able to work independently while collaborating and coordinating as part of a global program
- Strong interpersonal skills and the ability to work collaboratively with people at all levels of the organization
- Keen attention to detail and desire to take final ownership of content in deliverables
- Ability to quickly grasp key concepts, multitask, flexible, able to manage quick demands, change of priorities
- Strong analytical and assessment skills
- Strong time management skills and project management skills
- Proficient office productivity tools skills (Word, Excel, PowerPoint, Visio, SharePoint
15
Program Manager, Senior, Quality & Regulatory Resume Examples & Samples
- A Bachelor’s degree or your country’s equivalent
- Knowledge and experience in ERP (SAP, Oracle, or similar), Quality Management Software (TrackWise, TeamTrack, or similar), and/or Data Visualization Tools (QlikView, Tableau, Business Objects, or similar)
- Evidence of strong project management skills
- Fluency in written/spoken English
- An analytical and solution-oriented mindset, with the ability to set goals and motivate a multi-functional, remote team to achieve them
16
Program Manager Quality & Regulatory Resume Examples & Samples
- 12+ years of related experience in a medical device regulations industry
- 5+ years of management experience and played a quality site leader role in a matrixed organization
- Demonstrated knowledge & expertise on subjects mentioned below but not limited to
- SO Standards (i.e., 13485, 14971, 14001)
- US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD)
- Medical Device Design Control Requirements
- Lead / Internal Auditor Training
- Excellent Communication
- Excellent QA/Regulatory Writing Skills in English
- Proficient in Microsoft and other organizational tools
- Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts
17
Regulatory Program Manager Resume Examples & Samples
- Liaise with Project Managers, Development Leads and Business Analysts to plan, track and deliver large regulatory programmes
- Manage Governance and stakeholder reporting to broad range of senior stakeholders across the organisation
- Drive issues to resolution, not just track and report actions
- Track record as a Project Manager within the Financial Services/Investment Banking industry
- Experience in delivering Regulatory change projects from an end-to-end perspective as a project manager
- Experience of managing QA and UAT testing across multiple applications/teams
- Ability to manage and influence senior stakeholders
- Ability to work with disparate development teams using both waterfall and agile methodologies
- Good degree in IT (but will consider a strong Mathematics, Engineering, Arts or other Science degree, or equivalent Commercial experience)
18
Regulatory Labeling Program Manager Resume Examples & Samples
- 5+ years of regulatory affairs related experience with a Bachelor’s degree
- 3+ years of regulatory affairs related experience with a Master’s degree
- 2+ years of experience managing projects or programs under design controls including managing schedules, milestones, deliverables, and resources
- 1+ years of experience managing complex projects or programs, especially electronic products, labeling, medical devices or pharmaceuticals
- 1+ years of experience leading projects to completion
- Excellent people and communication skills (verbal and written)
- Technical Writing experience in a regulated environment
- Experience writing in or developing XML publishing systems (2+ years)
- Experience interacting with a broad range of functional groups and individuals at various levels of the organization
- Experience managing multiple projects successfully
- Experience using electronic tools for managing projects, routing reviews and approvals, allocating resources, etc
- 2+ years of experience in cross-functional, cross-geography project management
- 2+ years of experience in a labeling creation environment
- Experience working with cross-geography projects and teams
- Experience working on projects requiring localization/translation
- Experience in usability or human factors
- Experience working with content management systems
19
Global Regulatory Reporting Controls Oversight Transaction Review Program Manager Resume Examples & Samples
- Bachelor's Degree (Accounting or Finance Strongly Preferred)
- 7+ years of experience in regulatory reporting, including preparing, auditing, examining, or conducting transaction-level data quality reviews of the regulatory reports (e.g. FR Y-9C, FR Y-14Q/M, 14A, FFIEC 101)
- Strong technical knowledge of banking products (Wholesale Banking, Mortgage Lending, Consumer Lending, Trading Products) and U.S. GAAP (CPA, CFA, or equivalent certifications preferred)
- 7+ years of relevant internal control governance, audit testing and leadership experience, specifically in areas of accounting, testing, SOX internal control, and finance in a large, fast-paced, results-oriented company with a demonstrated history of success
- Strong relationship management skills to navigate the complexities of aligning stakeholders, building consensus and resolving conflicts in a large, distributed organization; proven ability to influence peers/stakeholders and senior leaders across various lines of business
- Proven ability to manage multiple and often competing priorities in a global environment; Ability to drive strategic initiatives with a track record of successful change and making difficult decisions
- Ability to decompose complex issues and drive timely decisions, knowing when to engage others for additional input, and when to act independently; Proven ability to manage and develop team members
- Strong executor that is able to lead across organizational lines and drive progress on priorities and issues
- Ability to communicate complex ideas in a clear and concise manner, shaping the opinions and actions of key stakeholders and gaining their trust.
20
Accreditation & Regulatory Program Manager Resume Examples & Samples
- Knowledge of regulatory requirements (TJC and CMS)
- Knowledge of the accreditation process
- Knowledge of survey preparation and required follow-up activities
- Skill in written and oral communications
- Skill in conducting mock regulatory surveys using the tracer methodology
- Ability to interpret, prepare, and present reports to management in both written and oral formats
- Ability to make presentations, design and provide training/education to staff and management
21
Regulatory Program Manager Resume Examples & Samples
- Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
- RAPs RAC strongly preferred. ASQ certifications also desirable
- Minimum of eight years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.)
- Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions
- Strong background in Design Controls
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards
- Experience in supporting international registrations and/or clinical investigations
- Proficient computer skills in Microsoft Office
- Understand LEAN concepts, methodologies and deployment
- Philips PCMS experience highly desired
- May require 10% travel annually with possibly some international
22
Compliance / Regulatory Program Manager Resume Examples & Samples
- Identifies, reads, analyzes, and interprets statutes and regulations related to Medicare, Medicaid, other third party payor billing requirements, HIPAA, HITECH, or other privacy and security requirements. Assesses impact on Intermountain operations and identifies operational and clinical areas affected. Translates complex legal text into understandable language and identify action steps for individuals and departments to act upon across corporation
- Provides guidance to affected individuals and departments developing action plans to implement new statutory and regulatory mandates, and ensures the completion, sufficiency, and sustainability of those plans. Serves as facilitator and point person to coordinate efforts among affected business segments within and external to Intermountain as new billing practices are implemented as needed. Tracks responses of operational areas implementing new billing requirements
- Manages multiple projects relating to area of focus. Leads teams, presents information, recommends processes, implement processes, etc
- Develops new and supports existing processes to identify and address compliance issues: Staffs Compliance Hotline (rotating schedule). Supports and/or conducts investigation of compliance issues. Assists in developing quality improvement plans
- Supports Work Group Compliance Specialists and their teams: Research of regulatory information, as needed. Assists with policy and procedure development, development of Work Group Compliance Team compliance-related training programs, and prioritizing compliance tasks based on risk assessments. Attends Work Group Compliance Team meetings as needed. Risk-assess issues related to that Work Group specialty. Assists Work Group in establishing compliance-monitoring methods. Provides Work Group with compliance education applicable to operational area
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Regulatory Affairs Program Manager Resume Examples & Samples
- BS/BA in Engineering, Sciences, or similar related field
- 5+ years of project management experience in medical device/pharma industry with BS/BA
- 3+ years of project management experience in medical device/pharma industry with advanced degree
- Quality System experience in a regulated industry (medical devices, pharma)
- US medical product regulations (medical devices or pharma)
- European Union medical product directives (medical devices or pharma)
- Demonstrated competencies and ability to apply independently: Self-Management, Goal Achievement, Personal Accountability, Planning & Organizing, Resiliency, Flexibility, Teamwork, Leadership, Interpersonal Skills, Diplomacy & Tact, Customer Focus, Problem Solving Ability, Conceptual Thinking, Persuasion, Decision Making, Creativity, Verbal & Written Communication
- Knowledgeable in worldwide regulatory requirements (e.g. FDA - QSR, ISO 13485, MDD, PAL, etc.)
- Project Management Professional (PMP) Certification Master’s Degree in Engineering, Sciences or similar related field
- Management of cross functional projects
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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Senior Regulatory Labeling Program Manager Resume Examples & Samples
- 7+years of related experience with a Bachelor’s
- 5+ years of related experience with a Master’s
- Minimum of 5 years of experience leading complex projects or teams
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Program Manager of Regulatory Compliance Resume Examples & Samples
- Bachelor’s degree in healthcare related field
- Certified Professional in Healthcare Quality (CPHQ), Healthcare Accreditation Certified Professional (HACP), or Joint Commission Certified Professional (CJCP) required, or obtained within 12 months of hire
- Current, non-encumbered health related licensure/certification (e.g. nursing, pharmacy, radiology, respiratory therapy, etc…)
- Clinical acute care experience
- 2 years of progressive management experience
- Experience in designing, implementing, and leading clinical outcome improvement programs
- Previous experience with Joint Commission survey coordination at facility level
- Excellent oral and written communication skills,
- Master’s degree in health care related field
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Regulatory & Standards Program Manager Resume Examples & Samples
- Understanding of a broad range of global environmental regulations on restricted substances, energy efficiency, eco-design, and labeling
- Understanding of existing multi-attribute environmental and sustainability standards on electronic products, such as EPEAT, IEEE 1680 and ULE 110
- Knowledge of EPEAT policies and processes, as well as experience with product verification processes
- Thrives in environments where attention to detail is required
- Comfortable driving outcomes that require influence without control
- Comfortable distilling information into crisp and concise messaging