Regulatory Affairs Engineer

Myn; Cambridge; Presencial; GBP 83.000 - 101.000; Jornada completa

Descripción de la vacante

Myn is seeking a Regulatory Affairs Engineer for a contract role in Cambridge to bridge engineering and regulatory oversight. You will build and maintain technical files and ensure products meet UK MDR 2002, UKCA and EU MDR/IVDR requirements throughout their lifecycle.

You will collaborate with design, quality and regulatory teams, provide input for design changes and risk management, and liaise with MHRA, notified bodies and test labs as required.

Formación

• 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.
• Engineering degree in a relevant field.
• Right to work in the UK.

Responsabilidades

• 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

Conocimientos

Regulatory engineering

Medical devices

Technical documentation

UKCA marking

Educación

Engineering degree (Biomedical/ME/EE)

Herramientas

Greenlight Guru

MasterControl

Veeva

Descripción del empleo

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.