Regulatory Affairs Manager
Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Opportunity
The function of a Regulatory Affairs Manager is to combine knowledge of scientific regulatory and business issues to enable products that are developed manufactured or distributed to meet the required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data
needed obtain this data and ensure that they are effectively presented for the registration of products worldwide.
Responsibilities
Regulatory Knowledge/Skills:
- Anticipate regulatory obstacles and emerging issues.
- Lead functional groups to complete a regulatory submission.
- Regulatory history guidelines policies standards practices requirements and precedents
- Regulatory agency structure processes and key personnel
- Principles and requirements of applicable product laws
- Principles and requirements of promotion advertising and labeling
- Interpret and apply regulatory requirements. Compile prepare review and submit regulatory submissions to authorities.
- Domestic and international regulatory guidelines policies and regulations
- Ethical guidelines of the regulatory profession clinical research and regulatory process
Communication:
- Communicate effectively verbally and in writing.
- Write and edit technical documents.
- Communicate and work with people from various disciplines and cultures.
- Negotiate internally and externally with regulatory agencies.
- Plan and conduct meetings; Work with crossfunctional teams.
- Clearly explain and articulate Regulatory plans to Senior leaders.
Cognitive Skills:
- Define regulatory strategy
- Perform risk assessment or analysis.
- Juggle multiple and competing priorities.
- Think analytically with good problemsolving skills.
- 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 indepth knowledge of business functions and cross group dependencies/ relationships.
- Follow scientific arguments identify regulatory scientific data needs and solve regulatory issues.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Influencing others to a win/win resolution appreciating all perspectives.
Leadership:
- Develops communicates and builds consensus for operating goals that are in alignment with the division.
- Provides leadership by communicating and providing guidance towards achieving business objectives.
- Interfaces with a variety of management levels on significant matters often requiring the coordination of activity across organizational units.
- May lead a crossfunctional or crossdivisional project team.
- Provides technical leadership to business units.
- Exercises judgment independently.
Required Qualifications
- Bachelors Degree in technical discipline or an equivalent combination of education and experience.
- Minimum 6 years Regulatory experience
- Experience with 510(k) applications IDEs PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fastpaced changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks prioritizes and meets deadlines in a timely manner.
- Strong organizational and followup skills as well as attention to detail.
- Ability to work independently with no oversight.
- Ability to identify and solve problems in a strategic manner.
- Ability to manage complex projects.
- Ability to be proactive and not reactive to anticipate changing business and regulatory environments.
PreferredQualifications
- Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields.
- Advanced degree
- 8 years Regulatory experience
- Experience working in a broader enterprise/crossdivision business unit model.
- Demonstrated experience at a supervisory/managerial level.
- Strong working knowledge of regulatory requirements for US EU (EU MDR) and other international geographies.
- Experience with medical device software requirements and software regulations.
- Ability to identify risk areas and escalate issues as appropriate.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Required Experience:
Senior IC
Employment Type
Full-Time
