Regulatory Affairs Specialist - Medical Devices - Cambridge

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

Job summary

Newton Colmore is seeking a Regulatory Affairs Specialist for Medical Devices in Cambridge. You will support a wide range of projects, work with engineers, scientists and designers, and help ensure compliance with global regulatory expectations across medical and non-medical sectors.

You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, monitor regulatory changes, contribute to regulatory planning, and support audits and lifecycle management from development through commercial

Qualifications

• Degree in regulatory affairs or a related field for medical devices.
• Experience developing or contributing to regulatory strategies.
• Familiarity with ISO 9001, ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Provide regulatory support across the business and multidisciplinary teams.
• Interpret regulatory requirements and advise on compliant pathways.
• Monitor changes in international regulations and communicate updates.
• Support internal and external audits and lifecycle management.

Skills

Regulatory affairs

Regulatory strategy

ISO 13485 knowledge

FDA 21 CFR 820 knowledge

Regulatory communications

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Job description

Regulatory Affairs Specialist - Medical Devices - Cambridge

A growing technology and product development organisation in Cambridge is looking to appoint a Regulatory Affairs Specialist to support a wide range of innovative projects. This role sits within a team that works closely with engineers, scientists and designers, helping them bring complex ideas to life while ensuring that every development pathway aligns with global regulatory expectations. The work is varied, fast‑moving and highly collaborative, giving you the chance to contribute to breakthrough technologies across both medical and non‑medical sectors.

You will be joining a quality and regulatory function that plays a central role in maintaining and improving the company's management systems. Rather than simply reviewing documents, this team is embedded in project activity, offering practical guidance that shapes product development from the earliest stages. Their work ensures that internal processes remain compliant with international standards and that clients receive the assurance they expect from a world‑class development partner.

In this position, you will provide regulatory support across the business, working with multidisciplinary teams and assisting senior members of the QA/RA group with the ongoing operation of the quality management system. The role offers exposure to a wide range of market areas, giving you the opportunity to broaden your regulatory knowledge and deepen your experience across multiple industries. You will be expected to apply your understanding of standards such as ISO 9001, ISO 13485 and FDA 21 CFR 820, helping teams navigate compliance requirements while still enabling innovation.

A key part of your work will involve monitoring changes in international regulations and standards, interpreting what they mean for the organisation, and communicating updates to colleagues. You will contribute to internal improvement initiatives, support external audit activities, and help ensure that quality and regulatory processes remain robust, efficient and aligned with business needs. This role requires someone who can balance the freedom needed for creative problem‑solving with the discipline required for regulated product development, finding pragmatic solutions that work in real‑world commercial environments.

To succeed, you will need to be a clear thinker who can work independently while supporting and enabling others. Strong communication skills are essential, as you will be building relationships across a wide range of stakeholders and taking ownership of initiatives that improve the way the business operates. You should be able to demonstrate experience in developing or contributing to regulatory strategies, interpreting regulatory requirements, and understanding the implications for downstream processes. Knowledge of medical device compliance will be particularly valuable.

It is expected that you will hold a relevant degree that has supported your move into a Regulatory Affairs position within the medical devices sector. It will also be important that you have contributed to a medical device that has progressed from early development through to commercial release, giving you a clear understanding of the full lifecycle and the regulatory considerations at each stage.

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