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
Compliance with regulatory reporting requirements and quality record documentation
Domain
Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Failure analysis, regulatory reporting (FDA, EU MDD), complaint file management, documentation review, lot documentation analysis, customer interface
Preferred skills
Analytical skills, organizational skills, decision-making, process improvement
Technologies
Excel, Word, PowerPoint, database
Responsibilities
Investigate and classify daily customer complaints, perform failure analysis reviews, file Malfunction MDR Reports, escalate adverse events, evaluate documentation for completeness, approve final complaint files, manage complaint workload, review lot documentation for anomalies, interface with customer service and hospitals, create customer response letters, participate in training and process improvement
Seniority
Mid-level, hands-on IC