Consultant: Life Sciences Team
Salary: £30000 - £50000
Job Status: Permanent / Full Time
I am currently looking for a Regulatory Affairs Associate & Senior Regulatory Affairs Associate for a high paying role based in Gloucestershire.
The main purpose of this role is to Liaise with my clients 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 (e.g. Design Dossier, Technical Files, 510(k), IDE supplements, annual reports, PMA and PMA supplements).
Interface with regulatory reviewers through written and oral communications as needed, assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
Liaise with other departments serving as a Regulatory representative on cross functional teams including, but not limited to, Quality, Product Development, Product Engineering, Operations & Manufacturing, Product Management, Clinical Research.
Detailed knowledge of the regulations and guidance for global markets including, but not limited to, EU, FDA, Canada, Australia, Japan, and other distributed markets.
Understanding of Quality Management Systems – FDA QSR, ISO 13485
Detail oriented and excellent written and verbal communication skills.
Experience with medical device vigilance systems
Minimum 2 years’ experience in medical device regulatory affairs.
Salary for the roles
Regulatory Affairs Associate – £30,000
Senior Regulatory Affairs Associate – £50,000
If you are interested, please drop me an email back with your CV and the best number to contact you on we can start a discussion.
I very much look forward to hearing from you.