Quality Assurance & Regulatory Affairs Specialist – MedTech

About the role

We are seeking an experienced Quality Assurance & 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 APAC, ensuring compliance throughout design and manufacturing.

Key responsibilities

• Maintain and develop quality management systems in line with ISO 13485 and CE‑Marking requirements.
• Lead internal audits and support external regulatory inspections.
• Prepare and submit regulatory documentation for product launches across multiple territories.
• Collaborate with engineering and product teams to embed compliance into design and manufacturing processes.
• Monitor and interpret changes in UK and European regulatory standards.

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 plus performance bonus.
• Pension scheme, free lunches and other employee benefits.
• Opportunities for professional growth and involvement in cutting‑edge device development.