Regulatory Affairs Engineer, Medical Devices — Cambridge

Newton Colmore; Cambridge; On-site; GBP 52,000 - 75,000; Full time

Job summary

Newton Colmore in Cambridge is seeking a Regulatory Affairs Engineer to support medical devices across development projects. You will work with design engineers and project teams to ensure regulatory thinking informs product architecture, design decisions and verification strategies from concept through release.

You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, contribute to design controls, track regulatory changes, and support audits, ensuring robust compliance while enabling

Qualifications

• Engineering or science degree required.
• Experience applying ISO 9001/ISO 13485 and FDA 21 CFR 820 in medical devices.
• Ability to translate regulatory requirements into design, verification and validation activities.

Responsibilities

• Provide regulatory guidance across multiple medical device projects.
• Maintain and contribute to the quality management system and audits.
• Interpret regulatory requirements and inform design decisions and verifications.
• Track and communicate regulatory changes affecting development.

Skills

Regulatory affairs

Quality systems

Regulatory strategy

Design controls

Cross-functional collaboration

Education

Engineering or science degree

Job description

Newton Colmore in Cambridge is seeking a Regulatory Affairs Engineer to support medical devices across development projects. You will work with design engineers and project teams to ensure regulatory thinking informs product architecture, design decisions and verification strategies from concept through release.

You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, contribute to design controls, track regulatory changes, and support audits, ensuring robust compliance while enabling