Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge

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

Responsibilities
Support the QA & Regulatory Affairs Manager in day‑to‑day operations.
Provide critical advice to the R&D; team on the development of medical devices.
Ensure compliance with FDA 510k, ISO 13485 and FDA 21 CFR Part 820 standards.




Relay information to teams responsible for regulatory submissions.

Qualifications
Knowledge of medical devices regulation (ISO 13485, FDA 510k) and, ideally, 21 CFR Part 820.
Experience in medical devices R&D; or design team; regulatory affairs or quality assurance background beneficial.
Understanding of QMS processes.
Degree (1–2:1) in engineering or sciences, though experience is weighted more heavily.

Advantages

Career progression, competitive salary, comprehensive advantages package, and share options.
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📌 Regulatory Affairs And Quality Assurance Assistant Cambridge Town Of Cambridge
🏢 Newton Colmore Consulting
📍 Town of Cambridge