RA Specialist - Submissions of High Risk Devices

This is a great opportunity within regulatory affairs to join a world leading biotech company based in Surrey. Join an international regulatory affairs and quality team and gain the opportunity to develop your career on the global platform. Our client produces combination devices further allowing you to develop your career with high risk products.

As the Regulatory Affairs Specialist in this role your responsibilities will include but will not be limited to:

• Working within the QA team to support new product development.
• Creating technical file dossiers and dealing with all necessary documentation
• Work on registrations and submissions, primarily CE marking and FDA 510k.

The role will involve working closely with the product development team to ensure compliance to global regulations. It will be a predominantly pre-market regulatory role, which will deal mainly with documentation, submissions and registrations.

The ideal candidate for this role will have experience within regulatory affairs within the medical device industry. You will have an understanding and will have worked with FDA 510k, European regulations and the ideal candidate must have experience working with cross-functional teams.

Call me Tim Bamigbade at NonStop Recruitment now for a confidential conversation. Contact me on regulatory@nonstop-devices.com or +44 (0) 207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a regulatory affairs professional within the medical device industry, please feel free to get in touch, to see other opportunities we may have within this field.