Senior Regulatory Affairs Specialist

Updated: May 04, 2024 07:51 AM GMT

Corin Group

Cirencester

Senior Regulatory Affairs Specialist to work at Corin, you will be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to make regulatory submissions and filings.

The ideal Senior Regulatory Affairs Specialist will have;
• 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.
• Extensive experience in medical device/orthopedics 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... More Detail