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Regulatory Affairs and Quality Assurance Assistant - Cambridge

Newton Colmore

Cambridge, Cambridgeshire, United Kingdom Full-time July 17, 2026

Found Description

Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge

Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company's Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and regulatory affairs advise on the creation of new products and the improvement of existing technologies.

It would be highly advantageous if you have knowledge of design processes, but it's not essential. This team does not just fill out quality assurance and regulatory documents; this is a team where they will be very involved with the R&D team, providing vital advice on the creation of medical devices, and ensuring the team operates within the FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.

It would be ideal if you have both quality assurance and regulatory affairs knowledge. However, people have moved into t...

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