Regulatory Postmarket Specialist
Core
Develop post-market strategies, plans, and reports (PMS Plans, PSURs) for medical devices to ensure regulatory compliance and support approvals.
Role type
Regulatory Postmarket Specialist
Builds
Regulatory documentation and post-market surveillance plans for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory reporting (FDA, EU MDR), Data analysis, Technical writing, Medical device knowledge, Cross-functional collaboration
Preferred skills
Process improvement, Project management
Technologies
Agile, Zoom, Box, SharePoint
Responsibilities
Create PMS Plans and PSURs, Summarize data for reports, Apply EU MDR and FDA regulations, Build stakeholder relationships, Lead meetings and develop communication tools, File documentation in systems
Seniority
Mid-level, some supervision