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

• 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

• 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, Master Control or Veeva.