- Individual must plan, implant and ensure compliance of the Technical File to the medical device regulation.
- Must have expertise of registering products with one of the EU authorized representatives.
- Should have in depth knowledge of both EU MDD and EU MDR.
- Individual must plan, implant and ensure compliance to Medical Devices regulatory programs.
- Coordinate activities/tasks and resources across affected departments.
- Coordinates and manages small to medium scope projects.
- Work direction is provided and is generally supervised and reviewed by more senior staff.
- Lead cross-functional teams and Project Management experience is plus.
- Minimum of 5 Years of Experience.
- Should be expert in Technical Files of medical devices.
- Should have experience with Medical Device Safety Service (MDSS - EU Authorized Rep) Registration
Job Type: Contract
- Medical Device Safety Service: 7 years (Preferred)