Operations Manager Medical Devices jobs

Regulatory expertise is fundamental to bringing medical devices safely to market. This publication invites experienced regulatory professionals to register their interest in future Regulatory Manager opportunities within the medical device sector, where your knowledge of ISO 13485, IEC 62304 and Class III device pathways could support the delivery of innovative technology.

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 Manager positions focused on navigating the complex regulatory landscape for Class III medical devices. Roles of this type typically involve supporting organisations through design controls, pre-market submissions and post-market compliance activities under ISO 13485 and IEC 62304 frameworks. You could work alongside cross-functional teams—engineering, quality, clinical and commercial—to ensure regulatory strategy aligns with product development timelines and market access goals.

Typical role overview

• Location: Edinburgh, City of Edinburgh, Scotland
• Type: Contract · Full-time
• Rate: £450–550 per day
• Domain: Class III medical device · regulatory affairs

What you would do

Typical responsibilities could include:

• Supporting the development and maintenance of regulatory strategies for Class III medical device programmes
• Coordinating with quality and engineering teams to ensure compliance with ISO 13485 and IEC 62304 throughout product development
• Preparing and managing regulatory submissions and documentation for pre-market and post-market activities
• Liaising with notified bodies and regulatory authorities on behalf of the organisation
• Maintaining and updating regulatory intelligence on evolving standards and guidance
• Contributing to internal training and documentation on regulatory requirements
• Supporting post-market surveillance and complaint handling procedures
• Collaborating across functions to integrate regulatory considerations into project planning

What you could bring

Most roles of this type require the following:

Must-have

• Bachelor's degree in Business, Life Sciences, Engineering or related discipline
• 3–7 years' experience in regulatory affairs, quality assurance or related compliance roles within medical device manufacturing or development
• Working knowledge of ISO 13485, IEC 62304 and Class III medical device regulatory pathways
• Familiarity with regulatory submissions, design controls and pre-market documentation
• Strong written and verbal communication skills
• Ability to coordinate across multiple stakeholders and manage competing timelines

Nice-to-have

• Certified Compliance Professional (CCP) certification
• Experience with FDA and/or European Union Medical Device Regulation (MDR) submissions
• Knowledge of post-market surveillance and complaint handling procedures
• Experience supporting clinical evaluation reports or technical documentation

What roles of this type could offer

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

• Opportunity to contribute to the regulatory strategy and market access of life-changing medical devices
• Exposure to complex, high-stakes regulatory projects and cross-functional collaboration
• Professional development in an evolving regulatory environment with emerging standards and guidance
• Potential for progression toward senior regulatory or quality leadership roles, where supported by performance and organisational opportunity
• Contract flexibility with a competitive daily rate of £450–550

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.