Regulatory Affairs Specialist
An excellent opportunity to work as a Regulatory Affairs Specialist for a global leading medical device manufacturer with range of products across oncology, gastroenterology, neurology, neurosurgery to name a few.
The role will ensure continued compliance with all relevant regulatory requirements of both internal corporate standards and external regulations. As well as post-market surveillance of medical device products ensuring continued compliance to all EU legislations.
- Previous experience working with EU MDD/MDR, ISO 13485.
- Post-market surveillance experience across medical device classes.
- Generate technical documentation for both Summary of Technical Documentation (STED) for CE and UKCA certification and for international product registration purposes.
- Knowledge from a registration perspective of active medical devices, risk assessment, clinical experience, post-market surveillance, quality compliance.
- University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
- Minimum of 2 to 5 years post qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
This role comes with an excellent benefits package including a generous pension scheme, private healthcare, life assurance, bank up to 12 extra days of holiday per year if you work overtime.
If you are interested in this role or would like more details, please email your CV firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Reference: JO-2205-491906
Website: Cpl Life Sciences
- Posted: 5th May 2022
- Expires: 2nd June 2022