Regulatory Postmarket Specialist
Core
Develop post-market strategies, plans, and reports (PMS Plans, PSURs) to ensure regulatory compliance for medical devices.
Role type
Regulatory Postmarket Specialist
Builds
Regulatory documentation and safety update reports for medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory reporting (FDA, EU MDR), data analysis, technical writing, medical device knowledge
Preferred skills
Process improvement, stakeholder collaboration
Technologies
Agile, SharePoint, Box, Zoom
Responsibilities
Create PMS Plans and PSURs, summarize data for reports, apply EU MDR regulations, lead meetings and develop communication tools, file documentation in systems, execute projects
Seniority
Mid-level, individual contributor
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