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
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
Desirable: SaMD, active implantables or IVD experience; FDA submissions (510(k), De Novo, PMA); eQMS tools such as Greenlight Guru, MasterControl or Veeva.
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Regulatory Affairs Engineer in Cambridge employer: Myn
Myn is an exceptional employer, offering a nurturing and supportive work environment for Nursery Room Leaders in Bristol. With generous benefits such as 33 days of annual leave, flexible working options, and extensive family and wellbeing support, employees are encouraged to thrive both personally and professionally. The company prioritises employee growth through tailored training and progression opportunities, making it a rewarding place to build a meaningful career in early years education.
