Regulatory Affairs Specialist Job Description
Regulatory affairs specialist
provides expert regulatory advice internally to Senior Management and Board of directors when needed to ensure compliance with FDA regulations.
Regulatory Affairs Specialist Duties & Responsibilities
To write an effective regulatory affairs specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Represents department in meetings with internal business units to advise them of regulatory complaint issues and ensure programmer compliance with customer facing regulatory requirements, including closed captioning, video description, and CALM compliance
Develops, implements and manages regulatory complaint intake programs and processes to ensure accurate case tracking, issue management and timely compliance with regulatory due dates
Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, to provide routine regulatory information to associates and affiliates
Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
Review and approve product labeling, advertising and promotional materials after evaluating compliance to the relevant European and internal regulations
Part of cross functional teams by providing regulatory guidance in the understanding of medical device regulations
Support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities
Prepare documentation for submission to National Competent Authority
Ensure full compliance with policies, procedures and validated systems
Provide input on regulatory-related issues associated with compliance and achieving the business plan
Regulatory Affairs Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Specialist
List any licenses or certifications required by the position: US, RAC, GMP, ASQ, RAPS, ETL, UL, CMC, CE, NOM
Education for Regulatory Affairs Specialist
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Chemistry, Technical, Biology, Medical, Pharmacy, Life Sciences, Education, Business
Skills for Regulatory Affairs Specialist
Desired skills for regulatory affairs specialist include:
FDA
EU
Standards
Medical device regulations
U.S.
Documentation
Communication and collaboration internally and externally
Compliance
Distribution
Obtaining approval
Desired experience for regulatory affairs specialist includes:
Ability to efficiently data mine database applications such as SAP, Enovia, and Register
RAP's certification would be a plus
BSc degree in a technical field, preferably in Life sciences
In lieu of education, equivalent related work experience required
Master's Degree in a technical field, preferably in Life sciences preferred
Experienced and consistent performer with demonstrated highly technical skills
Regulatory Affairs Specialist Examples
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Regulatory Affairs Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory affairs specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory affairs specialist
- Provide support for the development and update of the regulatory intelligence documentation for clinicals
- Provide divisional support to preparation and submission of regulatory applications to the local health authority.Contribute to Lead Process Improvement activities for the EU Regulatory team in liaison for RA manager
- Generate and maintain product compliance checklists
- Ensure regulatory compliance throughout launch and commercialization of products
- Supporting, compiling and reviewing all five modules of eCTD submission for regulatory compliance
- Track status and record submission life-cycle information in accordance with standards
- Review of product design changes of marketed products and preparation of internal regulatory assessments for necessary regulatory activities
- Collaboration with US and other RA partners to develop world-wide regulatory strategies to ensure timely approval of devices and continued regulatory support of marketed devices
- Review and analyze clinical evaluations reports, market preference evaluation documents, technical protocols, data and reports generated by R&D, Quality or other related departments
- Work out IVD and MD product registration plan and conduct effectively
Qualifications for regulatory affairs specialist
- Expert knowledge and significant hands-on experience in interpretation of the design control and risk management requirements/regulations
- Knowledgeable about industry business processes as it relates to Change Control
- Bachelor’s degree required, preferably in Life Sciences or related discipline
- 5+ years of relevant work experience in a regulatory affairs department
- Legal, Public Policy, Government, or Telecommunications experience preferred
- Proficiency in Word, PowerPoint, Excel and database programs
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Regulatory Affairs Specialist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory affairs specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory affairs specialist
- Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility
- Educate, train, & advise company professionals to ensure compliance with RA requirements
- Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility
- Author, review and compile documentation for product registration submissions
- Attend off-site regulatory agency (e.g., FDA) meetings
- Communicate with CFDA and prompt registration going smoothly
- Own CFDA registration sample test in China
- Review registration technical dossier and guide overseas RA providing documents as CFDA requirements
- Training to commercial associations on China regulations
- Other project support when needed within RA team
Qualifications for regulatory affairs specialist
- 0-3 years of professional experience in a foreign pharmaceutical company
- In-depth knowledge of regulations/legislation
- Strong in data gathering & interpretation
- Analytical, detail driven
- Bachelor degree from accredited college or university in science, biomedical engineering, Medical / scientific writing, public health administration
- 4+ years of regulatory affairs or related and/or equivalent experience
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Regulatory Affairs Specialist Job Description
Job Description Example
Our company is looking for a regulatory affairs specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory affairs specialist
- Maintains project documentation relevant to regulatory activities
- Ensures all staff adheres to professional standards and SOPs established for clinical research and help with the development of new SOPs as appropriate
- Modifies and/or develops informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA
- Organizes and coordinates IRB documentation for trials
- Archives study specific regulatory documentation and correspondence
- Organizes the required trials
- Ensure in a timely manner, the end-to-end labelling management for allocated portfolio (relevant submissions, translations, artworks development)
- Meet the deadlines for submissions, allocated trainings and validated systems
- Internal stakeholders (Marketing, Medical, Sales, Supply chain, Quality), other members of Regional Regulatory Affairs team
- National Competent Authority
Qualifications for regulatory affairs specialist
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society (desired)Regulatory Affairs
- A minimum of a Bachelor's degree in a Technical or Scientific discipline will be required
- 2 to 3 years practical experience (work, internship, co-op, ) in a medical device Regulatory Environment will be required
- Solid Knowledge of European regulations will be required
- Knowledge of US or international regulations is preferred
- Problem solving and decision-making skills will be required
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Regulatory Affairs Specialist Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory affairs specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs specialist
- Retrieve guidelines and other regulatory information from the internet, FDA, and other appropriate sources
- Interact with outside agencies such as FDA, Notified Bodies, international legal authorities, legal counsel, and other consultants
- Provide guidance and coaching for areas of responsibility to lower level team members
- Develop and initiate complex regulatory project plans
- Lead or represent Regulatory Affairs in project teams
- Provide support to RA manager for the management of clinical pre and post market studies in Europe
- Acts as a link between the clinical team and the local regulatory team for regulatory submission of clinicals
- Develops and maintain a link for Divisional RA team, stay up to date with new products certifications and recertifications
- Assist Regulatory Scientist Staff with regulatory tasks as needed \
- Provide support for entering clinical trials protocol information and study results into the NIH Clintrials.gov database ensuring that the database is kept current and accurate
Qualifications for regulatory affairs specialist
- Experience in Regulatory Affairs in Medical Devices (preferred) or Pharma industry
- Higher degree in sciences (chemistry, biology, toxicology, ecotoxicology)
- 2-5 year experience in regulatory affairs/product stewardship in chemical or pharmaceutical industry or consultancy for the sector
- Familiarity with data management systems and IT tools
- Client & business focused, well organized, sense of responsibility, flexible mindset, focused on relevant details, self-starter.Regulatory Affairs
- A minimum of 2 years experiences in medical devices industry, at least 1 year in IVD/MD registration
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Regulatory Affairs Specialist Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory affairs specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs specialist
- Prepare, submit and manage high quality scientific dossiers in accordance with relevant legislation
- Develop regulatory strategies for individual products
- Establish professional relationships with regulatory authorities
- Keep abreast of latest scientific and regulatory developments
- Provide regulatory support and guidance for regulatory submissions of initial 505(b)(2) application, amendments and supplements, Annual Reports, promotional materials to OPDP, labeling (including SPL) and PADER submissions
- Knowledge of eCTD structure, electronic publishing requirements and review
- Maintenance of various submissions schedules
- Review and tracking revisions/changes of product’s labeling
- Support document authoring, collection, publishing and QA of regulatory submissions
- Writing and review of regulatory SOPs
Qualifications for regulatory affairs specialist
- Understand CFDA regulation requirements on MD/IVD registration
- Must have a minimum of 3 to 5 years of registration and certification work experience, Experience in Certification bodies is a plus
- Knowledge of regional requirements of local registration and certification laws of Russia and other countries as applicable
- Knowledge of regional Import/Export regulations
- Multi-site experience, in a large sized company
- Requires the ability to provide solutions based on their own knowledge and industry experience base