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 to gather ...
★ Ready to Start Your European Career?
Take the next step and apply for this exciting opportunity