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Regulatory Affairs & Compliance Associate

IC Resources
Cambridge
5 days ago
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Regulatory Affairs & Compliance Associate

An exciting opportunity for a Regulatory Affairs and Compliance Associate has arisen with a fast-growing medical start‑up, based in Cambridge. As a Regulatory Affairs and Compliance Associate, you will play a key role in supporting the regulatory registration of the Software as a Medical Device (SaMD) and maintaining the ISO 13485‑compliant quality management system. You’ll work closely with the RA Manager and collaborate across R&D, engineering, and commercial teams to ensure compliance, support regulatory submissions, and help drive continuous improvement. You will commit to a hybrid working model, required onsite a minimum of 1 day a month.

Experience required
  • Regulatory submissions for notified bodies, e.g. FDA
  • Regulation understanding, including ISO 13485, FDA 21 CFR 820
  • QMS maintenance
  • Document control, including creation, review and approvals, with strong attention to detail
  • Bonus: experience with medical devices, pharma or medical research

Right to work in the UK without sponsorship is essential for this vacancy.

Seniority level
  • Entry level
Employment type
  • Full‑time
Job function
  • Legal


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