Description

+ The Adverse Event Specialist is responsible for both product complaint remediation and processing new complaints for reportability.

+ The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements.

+ It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.

+ 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 fi les 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, Regulatory Affairs, R&D, Operations, and other internal partners...