Description
The Medical Device Regulatory Affairs Specialist plans, coordinates, and submits regulatory approvals for new and modified medical devices, including 510(k) premarket notifications, EU MDR technical documentation, CE marking, and international registrations. The role also monitors regulatory changes, supports product development and design controls, assesses labeling and manufacturing changes, and ensures compliance with US, EU, and international requirements. It requires a bachelor’s degree, 3–5 years of medical-device regulatory experience, knowledge of FDA and EU regulations, and international device registration experience; the schedule is Monday–Friday, 8:00 a.m.–5:00 p.m., with health insurance and other benefits listed.
