- 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 and registrations as assigned ( 510(k) Design Dossier, IDE, Supplements, annual reports, PMA, and PMA supplements).
- Conduct post-market surveillance activities such as literature reviews, clinical study reviews, etc. Preparation of product Clinical Evaluation Reports and completion of annual updates.
- 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.
- A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics, Biomedical engineering) and/or a significant area of expertise developed through experience and a positive track record.
- Experience in medical device regulatory affairs, ideally Class 3
- Detailed knowledge of the worldwide regulations and guidance for medical devices.
- Understanding of Quality Management Systems - FDA QSR, ISO 13485.
- Detail-oriented and excellent written and verbal communication skills.
- Experience in orthopedics is preferable but not essential.
- 25 days holiday plus bank holidays.
- Excellent pension – up to provided by Corin when you contribute 4%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment
- Pay Type Salary
- Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK
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Description
Senior Regulatory Affairs Specialist
Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Regulatory Affairs Specialist will require 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;
The ideal Senior Regulatory Affairs Specialist will have;
You will receive a competitive salary and discretionary annual bonus as well as;
Other details
