Senior Regulatory Affairs Specialist
Corin
- Cirencester, Gloucestershire
- Permanent
- Full-time
- Liaise with Corin Ltd R&D and Product Management to provide regulatory input into NPI Project Core teams
- Timely preparation and submission of regulatory applications (EG 510(k), CE Marking, Design Dossier, IDE, Supplements, Annual Reports, PMA and PMA supplements)
- Interface with regulatory reviewers through written and oral communications as needed and assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
- Liaise with other Corin Ltd departments serving as a Regulatory representative on cross-functional teams including, but not limited to, Corin Quality, Product Development, Product Engineering, Operations & Manufacturing, Product Management, Clinical Research, IT, and Corin Group subsidiaries.
- Undertake deputized duties as required.
- A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics) and/or a significant area of expertise developed through experience and a positive track record.
- Experience in medical device/orthopaedics regulatory affairs, ideally Class 3 is essential
- Experience in clinical evaluation report writing for class 3 medical devices is essential
- Detailed knowledge of the worldwide regulations and guidance for medical devices.
- Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
- Understanding of Quality Management Systems - FDA QSR, ISO 13485.
- Detail-oriented and excellent written and verbal communication skills.