REMOTE Senior Medical Device Regulatory Compliance Manager
- Los Angeles, CA
Required skills & experience:
- Bachelor’s degree required; advanced degree or Law Degree preferred.
- Experience with medical device regulatory submissions (EUA, 510(k) or PMA).
- You have at least 7 to 10 years of experience in medical device and/or biopharmaceutical and/or agency/medical education company experience.
- Comprehensive knowledge of regulations and guidance governing medical device development and maintenance.
- Proven ability to lead and influence others and to collaborate effectively with peers, teams, and senior leadership.
- Clear and effective verbal and written communication skills, and persuasive project management and presentation skills.
- Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
- Experience working on cross-functional teams and within a review committee.
- Ability to implement and manage multiple projects simultaneously, with high attention to detail.
- Prior experience in a fast-paced startup environment a plus
What you need to know:
- This is a leadership position within Compliance and will represent the department on product teams and requires a comprehensive understanding of strategic labeling.
- You will have significant interactions with Marketing, Medical, Technology, and Product teams, leading to product launch.
- Participate in the product development team for early development products to provide labeling leadership in developing target labeling concepts to guide the design and analysis plan for clinical studies.
- Manage regulatory submissions to FDA; draft responses to Agency queries and revised labeling and other requirements for submissions; track FDA requests and responses.
- Prepare the submission documents including coordination of all exhibit materials.
- Maintain and tracks documents in the document repository as appropriate.
- Serve as an internal expert on regulations (FDA and state-level regulations), guidance, and enforcement trends governing the promotion of medical devices, and provide guidance to others.
- Ensure compliance with applicable laws, regulations, and FDA guidelines.
- Coordinate with the laboratory Quality Assurance Supervisor to ensure regulatory requirements are being met.