Myn
Regulatory Affairs Engineer
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Regulatory Affairs Engineer
We're looking for a Regulatory Affairs Engineer for a contract role with a medical device manufacturer. This is a technically focused position bridging engineering and regulation. You'll build and maintain technical documentation and make sure products meet applicable standards and regulations throughout their lifecycle.
Location: Cambridge, UK
Day rate: £450–£550 per day (IR35 status to be confirmed)
Contract: Initial 6–12 months, likely extension
What you'll do:
- Compile and maintain technical files and design dossiers under UK MDR 2002 (UKCA) and EU MDR/IVDR
- Support MHRA device registration, UKCA marking and UK Responsible Person requirements
- Provide regulatory input to design and development, including V&V evidence and design changes
- Support ISO 14971 risk management and clinical evaluation inputs
- Ensure compliance with ISO 13485, IEC 60601, IEC 62304, IEC 62366 and ISO 10993 as applicable
- Liaise with notified/approved bodies, test labs and the MHRA
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What you'll bring:
- Engineering degree (Biomedical, Mechanical, Electrical/Electronic, Software) or related discipline
- 3–6 years' regulatory or quality/regulatory engineering experience in medical devices
- Experience compiling technical documentation for UKCA and/or CE marking under MDR/IVDR
- Strong knowledge of ISO 13485 and ISO 14971
- Right to work in the UK
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Desirable:
- SaMD, active implantables or IVD experience
- FDA submissions (510(k), De Novo, PMA)
- eQMS tools such as Greenlight Guru, MasterControl or Veeva
Interested? Apply via the link or message the Myn team for a confidential conversation.
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