Regulatory Affairs Specialist

RESPONSIBILITIES:

Control and Maintain the Regulatory Movex Module:  Release products ?on hold? and place items ?on hold? as needed to control the flow of product into commercial distribution.  Compile information for permits and obtain and maintain these permits as required.  Typical permits would include DEA, FDA, USDA, etc.  This include but is not limited to:  Certificates of Exportability, Certificates to Foreign Governments USDA, and CDC permits, U.S. Department of Department of Wildlife etc.  Create and maintain all FDA facility registrations and device listings.  Coordinate the Lot Release of CBER regulated products as applicable.  Ensure that all appropriate requirements are met and that all necessary documentation is in place for product sold as either Research Use or Investigational Use within the United States.  Compilation of any Annual Reports required under the direction of the Sr. RA Specialist responsible for the product in question.

 

 

QUALIFICATIONS:

Bachelors degree in a scientific discipline or equivalent combination of education and experience. Minimum two years regulatory experience in medical devices, In-Vitro Diagnostic devices required.  Excellent verbal and written communication skills required.  International registration experience required. Experience in Labeling reviews, 510K submissions, PMA submissions required. Good negotiation and diplomatic skills.  Must have good PC skills and be proficient in Office Windows, particularly Word and Excel.  Excellent organizational and presentation skills required.