Clinical Specialist, Post Market Surveillance
Core
Clinical subject matter expert responsible for global medical device reporting (MDR), investigation of product complaints, and regulatory compliance for heart failure devices.
Role type
Clinical Specialist, Post Market Surveillance
Builds
Regulatory compliant medical device reporting and complaint investigation processes
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Medical device reporting, complaint investigation, regulatory compliance, cross-functional collaboration, training delivery, critical thinking, documentation management
Preferred skills
Global medical device reporting regulations, complaint handling frameworks
Technologies
Regulatory databases, QMS systems
Responsibilities
Ensure global medical device reports are filed within regulatory timeframes, represent Product Surveillance at cross-functional meetings, support regulatory agency inspections, conduct product complaint investigations, train employees on complaint handling, make decisions regarding MDR submissions to regulatory agencies
Seniority
Mid-level, independent contributor