REMOTE Senior Medical Device Regulatory Compliance Manager

Seasoned Recruitment - Los Angeles, CA

overview
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.




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