Post Market Surveillance Specialist
Core
Investigate customer complaints, perform failure analysis, and ensure completeness of complaint documentation for medical devices.
Role type
Post Market Surveillance Specialist
Builds
Complaint files and regulatory reports
Domain
Medical Devices / Regulatory Compliance
Required skills
Failure analysis, Regulatory reporting (FDA/MDD), Complaint file management, Lot documentation review, Documentation evaluation
Preferred skills
Cross-functional communication, Analytical skills, Organizational skills, Decision-making, Process improvement
Technologies
Excel, Word, PowerPoint, Database
Responsibilities
Investigate and classify daily customer complaints, Perform failure analysis investigations, File Malfunction MDR Reports, Escalate adverse events or new failure modes, Review lot documentation (DHRs) for anomalies, Interface with Customer Service and hospitals, Create customer response letters, Approve final complaint files for closure
Seniority
Mid-level, hands-on IC