Regulatory Affairs Specialist – MedTech

About the role

We are seeking a Regulatory Affairs Specialist to join a fast‑growing medical‑device company in Cambridgeshire. You will work on complex, life‑saving technologies destined for Europe, North America and the APAC region, ensuring compliance throughout design and manufacturing.

Key responsibilities

• Maintain and update regulatory documentation for multiple product ranges.
• Conduct internal audits and support external inspections.
• Interpret and apply ISO 13485, CE Marking and other relevant standards.
• Collaborate with engineering and quality teams to embed regulatory best practice.
• Support product launches across Europe, the US and APAC.

Required profile

• 2‑5 years of experience in quality assurance and regulatory affairs within the medical‑device sector.
• Degree in engineering, biomedical engineering or a related scientific discipline.
• Strong attention to detail and ability to work autonomously.

Required skills

• ISO 13485
• CE Marking

What we offer

• Competitive salary £45,000‑£49,000 per year.
• Performance bonus and pension scheme.
• Free lunches and a range of additional benefits.
• Opportunities for professional growth and development.