We are working with a global Medical Device company who, due to their exceptional continued growth, have an exciting opportunity for a Senior Regulatory Affairs Specialist to join the team in Berkshire.
As our new Senior Regulatory Affairs Specialist you will be working closely with the R&D Teams to lead RA activities on New Product Development projects whilst supporting changes for existing and pre-released products.
This is a fantastic opportunity for an experienced Regulatory Affairs professional from the Medical Device sector with experience of Active Medical Devices
Experience, Education and Knowledge Required:
- Proven and demonstrable Regulatory Affairs experience
- Sound knowledge of the regulatory framework for Medical Devices
- Experience working with International Standards IEC/EN 60601-1/ 60601-1-2/ 62304/ 62366, ISO 14971 and ISO 13485
- Good working knowledge of Design Control, Software Life Cycle, Risk Management, Validation & Verification processes
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities