EU Post Market Surveillance Specialist
Core
Reviews, evaluates, and manages product complaints to determine vigilance reporting requirements and supports regulatory compliance for medical devices.
Role type
Post Market Surveillance Specialist
Builds
Regulatory compliance reports and complaint databases
Domain
Medical Devices / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
EU MDR (2017/745), UK MDR, Swiss MedDO, complaint handling, data collection, regulatory reporting, database management, cross-functional communication
Preferred skills
US FDA 21 CFR Parts 803/806/820, TrackWise, ERP/CRM (SAP/Salesforce)
Responsibilities
Evaluate incoming complaint information and maintain records in electronic databases; Conduct follow-up investigations with internal resources and customers; Determine reportability of complaints per regulatory requirements; Evaluate and report device malfunctions to European regulatory agencies; Collect, trend, and escalate Post Market Surveillance data
Seniority
Junior to Mid-level, hands-on IC