Job Title: Adverse Events SpecialistJob Description
The Adverse Events Specialist is tasked with managing product complaint remediation and processing new complaints for reportability. This role involves reviewing both historical and newly received complaints to determine Medical Device Reporting (MDR) reportability in accordance with current procedures and regulatory requirements. The specialist ensures all MDR submissions comply fully with FDA reporting requirements, 21 CFR 803, and Quality System regulations.
Responsibilities

+ Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.

+ Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.

+ Work cross-functionally with Quality, Regu...