EU Post Market Surveillance Specialist
Core
Evaluates medical device complaints, determines vigilance reporting requirements, and conducts follow-up investigations to support regulatory compliance.
Role type
Post Market Surveillance Specialist
Builds
Regulatory compliance reporting and complaint management processes for medical devices
Domain
Healthcare / Medical Devices
Deliverable
client delivery
Required skills
Medical device complaint handling, regulatory reporting (EU MDR, MDD), data collection and trending, cross-functional collaboration, database management
Preferred skills
US FDA complaint handling knowledge, ERP/CRM software proficiency
Technologies
TrackWise, SAP, Salesforce
Responsibilities
Evaluate incoming complaint information and maintain records in electronic databases, process and close complaint-handling activities, conduct follow-up investigations to gather additional information, determine reportability of complaints per regulatory requirements, evaluate and report device malfunctions to European regulatory agencies, collect and trend Post Market Surveillance data
Seniority
Junior to Mid-level, hands-on IC