Regulatory Affairs Specialist - Cirencester, UK
Corin, United Kingdom
Job Description
Corin is seeking a 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 having the ability to make regulatory submissions and filings.
Corin is a medical device manufacturer based in Cirencester with innovative robotically assisted platforms for joint (hip and knee) replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The key responsibilities of the Regulatory Affairs Specialist are to;
- Liaise with Corin Ltd Ramp;D and Product Management to provide regulatory input into NPI Project Core teams.
- Prepare and submit regulatory applications and registrations as assigned (e.g. 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 amp; Manufacturing, Product Management, Clinical Research, IT and Corin Group subsidiaries.
Requirements
The ideal Regulatory Affairs Specialist will have;
- A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics, Biomedical engineering) and / or significant area of expertise developed through experience and positive track record.
- Some experience in medical device regulatory affairs or a strong interest
- 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 orthopaedics is preferable but not essential.
Benefits
You will receive a competitive salary and annual bonus as well as;
- 25 days holiday plus bank holidays.
- Excellent pension up to 9.7% provided by Corin when you contribute 5%
- 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