Medical Device Specialist jobs

Regulatory Affairs roles in this area could focus on navigating the complex compliance landscape for medical devices, ensuring products meet rigorous standards while progressing through the product lifecycle. A central theme could be managing documentation, liaising with regulatory bodies, and supporting product launches in a fast-paced, collaborative environment.

Please note the content of this advert does not represent a live vacancy.

About the opportunity

This is an opportunity to register your interest in future Regulatory Affairs roles within the medical device sector, positions that could support the delivery of compliant, life-changing technology to market.

Roles of this type may sit within a dynamic, collaborative engineering culture where regulatory expertise directly influences product strategy and timelines. The work could involve partnering across quality, engineering and commercial teams to maintain ISO 13485 and IEC 62304 compliance, manage Class III device submissions, and keep programmes moving through the regulatory pathway with scope to contribute to strategic decisions.

Typical role overview

• Location: Edinburgh, City of Edinburgh, Scotland — hybrid, with flexibility
• Type: Contract · Full-time
• Rate: £450–550 per day
• Domain: Class III medical device · regulatory compliance and lifecycle management

What you would do

Typical responsibilities could include:

• Supporting regulatory strategy and compliance planning for Class III medical device programmes
• Preparing and maintaining regulatory documentation, including design history files (DHF), technical files and submission packages
• Liaising with regulatory authorities (MHRA, FDA, notified bodies) on behalf of the business
• Coordinating cross-functional input on regulatory requirements, timelines and risk mitigation
• Maintaining and updating quality management systems (QMS) documentation aligned to ISO 13485 and IEC 62304
• Contributing to product lifecycle management, including pre-market and post-market compliance activities
• Supporting internal teams on regulatory interpretation and compliance best practice
• Tracking regulatory updates and advising on impact to current and future programmes

What you could bring

Most roles of this type require the following:

• 3+ years' regulatory affairs or compliance experience, ideally within medical device manufacturing or healthcare
• Working knowledge of ISO 13485, IEC 62304 and Class III medical device regulations
• Experience with regulatory submissions to MHRA, FDA or notified bodies
• Strong familiarity with design history files (DHF), technical files and regulatory documentation
• Bachelor's degree in Business, Life Sciences, Engineering or related discipline
• Excellent written and verbal communication skills
• Attention to detail and ability to manage multiple workstreams under tight timelines

Nice-to-have:

• Certified Compliance Professional (CCP) or equivalent certification
• Experience with post-market surveillance and adverse event reporting
• Familiarity with SAP or equivalent QMS platforms
• Knowledge of related standards (ISO 14644, ISO 9001 or IEC 61010)

What roles of this type could offer

Most roles of this type offer the following, dependent on the industry and seniority of the role:

• Involvement in bringing regulated medical devices to market and supporting patient outcomes
• Exposure to regulatory strategy and cross-functional collaboration with engineering, quality and commercial teams
• Potential to develop deeper regulatory expertise and progression toward senior or specialist roles
• Flexibility, professional development support and the opportunity to work within a forward-thinking compliance environment
• Contract flexibility with clear day rates and the scope to contribute immediately to live programmes

About SThree

SThree is the global STEM workforce consultancy.
We advise businesses, build expert teams and deliver project solutions to outpace tomorrow, together.

Across the UK, we connect talented specialists with cutting-edge opportunities across technology, engineering, life sciences and financial services supported by our offices in London, Birmingham, Manchester, Glasgow and Leeds

How to register interest

If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career.

Disclaimer:
Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.