REGULATORY AFFAIRS SPECIALIST

You will be responsible for managing all assigned regulatory activities including ensuring company products meet regulatory requirements; ensuring timely preparation of organized, scientifically valid U.S. and international regulatory filings and communicating with U.S. and international regulatory authorities.

The position is also responsible for developing and implementing regulatory strategies for new and modified products, determining when technical changes are reported to regulatory authorities, and managing the MDR/vigilance reporting system.

RESPONSIBILITIES:


* Manage preparation and compilation of U.S. and international regulatory filings, including 510(k), IDE, PMA, Design Dossier, and Technical File
* Act as a liaison between the company and the FDA, Notified Bodies, Competent Authorities or other regulatory bodies
* Develop and implement regulatory strategies for new and modified products
* Participate in material review board activities
* Provide regulatory advice and guidance to product/project teams and other functional groups
* Approve regulatory documentation necessary to ship clinical materials to investigational sites
* Prepare and maintain regulatory files, activity logs and contact reports
* Manage complaint handling/MDR/vigilance reporting programs; ensure that complaints and product issues are reported to the appropriate regulatory bodies
* Responsible for initiating device recalls, preparing recall documentation for FDA review, and maintain regulatory files for recalled devices
* Prepare export certificates, medical device listings, and establishment registrations.
REQUIREMENTS
EDUCATION:
BA/BS degree minimum; some graduate work preferred.
RAC accreditation a plus.

EXPERIENCE:
* Eight years experience within the regulated industry (Medical Device and/or Pharmaceutical)
* Working knowledge of medical device and drug development processes, and U.S., EU, and Canadian laws, regulations, guidance documents, and practices for drugs, medical devices, and quality systems required.

Experience with other international regulatory submissions:
Good Laboratory Practices Standards
Standards to include: ISO, AAMI, ASTM, ICH, and USP.