The Sr. Regulatory Affairs Specialist works cross-functionally to advise on and maintain regulatory compliance across the business. This individual will prepare US and European regulatory submissions, provide guidance on product development, and help enhance the department's processes and procedures to support the organization's growth. The position is highly dynamic and involves pre- and post-market regulatory strategy within multiple markets.
- Proactively develop and execute regulatory strategies, projects, and plans.
- Support US regulatory submissions (IDE, PMA, supplements, and periodic reports) and continuous compliance activities.
- Support CE Marking including MDR applications, maintaining technical documentation, and associated compliance activities.
- Engage with regulatory bodies (FDA/Notified Body) for requests for information and during meetings, managing the interactions professionally and providing information in an accurate and timely manner.
- Monitor regulatory changes and updates to ensure compliance with all applicable regulations, standards, and guidelines in the US and Europe.
- Maintain knowledge of industry best practices and trends in regulatory affairs.
- Work with cross-function teams, including Clinical, R&D, and Quality to provide guidance on regulatory strategy and support these teams to carry out projects in alignment with the strategy.
- Support continuous compliance activities for the business, e.g., site and product registrations, product changes, audits, etc.
- Perform all activities in compliance with applicable regulations, company policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
Education or Certification Requirements
- BS in Life Sciences, Engineering, or related disciplines.
- RAPs Certification preferred.
Professional Work Experience
- 5+ years of related experience in Regulatory Affairs, or advanced degree with a minimum of 3 years' experience.
- Experience in higher device class (IIb and III) preferred.
- Experience in IDEs, PMAs, and MDD/MDR transition preferred.
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Strong working knowledge of US (21 CFR) and EU (MDR) medical device regulations.
- Experience and proven ability in preparing regulatory submissions e.g., IDE, 510(k), PMA, technical documentation.
- Knowledge of Quality Systems requirements such as QSR, ISO 13485, GxP.
- Strong project management skills and ability to manage complex projects and timelines within a team environment.
- Ability to identify compliance risks and escalate when necessary.
- Close involvement in medical device product development cycle.
- Demonstrated ability to stay abreast of changing US and international regulations and standards.
- Excellent computer aptitude and document formatting and publishing skills.
- Strong problem-solving skills and ability to deal with changing priorities.
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamics organizations.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with a keen sense or urgency to get the job done well.
- Evidence of "hands-on" experience and expertise.
- Proved and successful track record as a team-player and collaborator in small working environments.
- Highly organized and detail oriented with a passion to deliver quality results.
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation.
- Highest levels of professionalism, confidence, personal values and ethical standards.
Additional Position Requirements:
- Minimal domestic and international travel may be required.