Quality Assurance & Regulatory Affairs Specialist – MedTech in Cambridge)

Quality Assurance & Regulatory Affairs Specialist – MedTech

A growing medical devices company in Cambridgeshire is seeking an experienced QARA specialist to join our team of experts.

Responsibilities

• Develop and implement quality assurance and regulatory strategies for medical devices launched in Europe, North America and APAC.
• Ensure compliance with ISO 13485, CE Marking and other relevant standards across design and manufacturing processes.
• Conduct internal audits to verify adherence to regulatory and quality requirements.
• Collaborate with cross‑functional teams to maintain regulatory best practice throughout the product lifecycle.
• Shape and continuously improve quality and regulatory processes.

Qualifications

• Minimum of 2 to 5 years of experience in quality assurance or regulatory affairs within the medical device industry.
• Strong knowledge of ISO 13485, CE Marking and related UK/European regulatory standards.
• Background in engineering, biomedical engineering or a related scientific discipline (minimum bachelor’s degree). Scientific background acceptable.
• Experience performing internal audits.

Benefits

• Competitive salary package with performance bonus.
• Company pension scheme.
• Free lunches and other benefits.

Please note the position is based full‑time in the office.

If you would like to find out more about the company and this role, please submit a confidential application.

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