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

Regulatory Affairs Engineer - Medical Devices - Cambridge

A leading technology and product development organisation in Cambridge is seeking a Regulatory Affairs Engineer to support a diverse portfolio of complex engineering projects. Working at the intersection of design, innovation and compliance, you will partner closely with design engineers, scientists and project teams to ensure that every development pathway is grounded in robust regulatory thinking. The work is fast-paced, technically varied and highly collaborative, giving you the opportunity to influence breakthrough technologies across both medical and non-medical sectors.

You will join a quality and regulatory function that is deeply embedded within engineering activity. Rather than operating as a separate review layer, this team works directly alongside designers and technical specialists, providing practical regulatory guidance that shapes product architecture, design decisions and verification strategies from the earliest concept stages. Their involvement ensures that development processes remain aligned with international standards and that clients receive the confidence expected from a world-class engineering partner.

In this role, you will deliver hands-on regulatory support across multiple projects, contributing to the operation and continuous improvement of the quality management system while enabling engineering teams to progress efficiently. You will apply your knowledge of standards such as ISO 9001, ISO 13485 and FDA 21 CFR 820 to help teams interpret requirements, manage design controls and navigate compliance considerations without compromising innovation. The breadth of project exposure will allow you to deepen your regulatory engineering expertise across a wide range of technologies and market areas.

A key part of your work will involve tracking changes in international regulations and standards, assessing their impact on ongoing development activities, and communicating clear, actionable guidance to engineering colleagues. You will support internal improvement initiatives, contribute to external audit preparation, and help maintain quality and regulatory processes that are both rigorous and practical for real-world product development. This position requires someone who can combine structured regulatory thinking with the creativity needed to support engineering problem-solving, offering pragmatic solutions that work in commercial environments.

To succeed, you will need strong communication skills and the ability to build effective relationships with design engineers and multidisciplinary teams. You should be able to demonstrate experience in developing or contributing to regulatory strategies, interpreting technical requirements, and understanding how regulatory considerations influence design, verification and downstream processes. Experience within the medical device sector will be particularly valuable.

You will be expected to hold a relevant engineering or scientific degree and have contributed to the development of a medical device from early design stages through to release, giving you a clear understanding of the full lifecycle and the regulatory engineering considerations at each phase.

This is an excellent opportunity to join a forward-thinking organisation where you can expand your regulatory engineering expertise, contribute to meaningful innovation and play a key role in shaping how new technologies reach the market.