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Sr. Manager or Director of Regulatory Affairs

Sr. Manager or Director of Regulatory Affairs

Responsibilities


This is a hands-on position that will be responsible for all regulatory filings.  They will work with Clinical, Engineering, and QA to organize, write, submit, and manage all components of a modular PMA.  They will be the primary contact of communication with FDA for Regulatory issues.  They will work closely with the CMO and VP of Clinical & Regulatory Affairs to ensure accuracy of data, statistics, and submissions.  As needed, they will help to develop regulatory strategies for US and OUS markets.

  • Develop and implement regulatory strategies.
  • Personally prepare technical documentation to support global regulatory approvals.
  • Serve as representative for product regulatory and safety issues to agencies.
  • Provide regulatory input to product lifecycle planning.
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders.
  • Ensure compliance with product post-marketing approval requirements.
  • Review and approve labeling to ensure compliance with regulations and company policy.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Review, approve and help develop quality, preclinical and clinical documentation for submission filing.
  • Maintain annual licenses, registrations, listings.


Qualifications

  • A minimum of 15 years of medical device Regulatory Affairs experience.
  • A history of successful FDA submissions with PMA experience most desirable.
  • Knowledge and experience with Class 3 medical device requirements including pre-clinical testing and manufacturing requirements.
  • MS or BS degree in a technical discipline (eg biology, chemistry, engineering).
  • RAPS Regulatory Affairs Certification preferred.
  • Good organization and writing skills.
  • Good communication with all levels of the company and FDA.
  • Knowledge of medical product design control and manufacturing quality system principles and practices.

Additional Info

Job Type : Full-Time

Education Level : ""

Experience Level : ""

Job Function : ""

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