Spec Adverse Events

The Adverse Event Specialist reviews product complaints to determine Medical Device Reporting (MDR) reportability in compliance with FDA regulations and Quality System requirements. The role involves analyzing historical and new complaint data, collaborating cross-functionally with Quality and Regulatory Affairs teams, and submitting reports via the FDA eMDR portal. This position ensures full compliance with 21 CFR 803 and 820.198 while managing strict remediation timelines.