Senior Regulatory Affairs Specialist - Cirencester, United Kingdom - Corin Group

Description

Corin is seeking a Senior Regulatory Affairs Specialist to 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.

You will be part of the Global Regulatory Affairs team based in our Cirencester Head Office on a permanent hybrid contract, a minimum of 2 days a week onsite

The key responsibilities of the Senior Regulatory Affairs Specialist are to;

• 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.

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.
• 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.