Senior Regulatory Affairs Specialist

Corin ,
Cirencester, Gloucestershire
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Job Description

Description Corin, a rapidly growing orthopaedic medical device business, is currently looking for a Senior Regulatory Affairs Specialist to work within the Regulatory team based in our head office in Cirencester, Gloucestershire. The main purpose of the Senior Regulatory Affairs Specialist is 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 having the ability to make regulatory submissions and filings. 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. Requirements The ideal Senior Regulatory Affairs Specialist will have; * A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics) and / or significant area of expertise developed through experience and positive track record. * Extensive experience of 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. * Experience in orthopaedics is highly desirable but not essential. Benefits You will also 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 * Option to join the cycle to work scheme * Subsidised canteen Corin manufactures clinically proven implants (hip, knee, and ankle and shoulder replacements) at our head office in Cirencester and we distribute these worldwide to countries such as Japan, USA, Australia and France. Our tag line " Connected Orthopaedic Insight" shows that we are revolutionising the orthopaedic market as we are now using technology (OPS, Omni & RPM) to understand and provide patient data to the surgeon and healthcare providers to deliver better outcomes to everyone. Corin is the 2nd largest employer in Cirencester with over 400 employees who consist of Manufacturing (CNC operatives), Engineering (quality and production engineering), Quality Assurance, Regulatory, Marketing, Sales, HR, Finance, IT, Supply Chain and Logistics. We are easily accessible from the A419, A435, M5 and M4 if you live in Swindon, Wiltshire, Gloucester, Cheltenham, Bristol, Bath, Stroud or Oxford Corin could be the company for you

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