Project Support Specialist

3 weeks ago


Hyattsville, Maryland, United States BlackFish Federal LLC Full time

BlackFish Federal LLC is hiring a skilled Project Support Specialist - FDA Compliance to join their team. In this role, you will provide critical support to device manufacturers, health care providers, and user facilities in submitting adverse event reports to the U.S. Food and Drug Administration (FDA).

Your main responsibilities will include resolving submission issues with adverse event reports, conducting quarterly User Facility audits, collaborating with device manufacturers, User Facilities, and reporters to resolve data anomalies, and redacting patient and/or manufacturer confidential data as needed.

This role is based in Landover, MD, and offers a competitive salary of $75,000 per year, plus benefits. If you have experience in regulatory affairs and are committed to ensuring compliance with FDA regulations, we encourage you to apply.



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