Medical Devices Regulatory Affairs jobs

We are looking to register interest in Regulatory Affairs professionals who could support the advancement of medical device programmes through regulatory strategy, compliance and submission management. Roles of this type could involve guiding products through complex regulatory pathways, ensuring adherence to standards such as ISO 13485 and IEC 62304, and managing interactions with regulatory bodies to bring safe, effective devices to market.

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 medical device development, positions that could support the delivery of innovative healthcare solutions to patients and healthcare systems.

Roles of this type may sit within collaborative, regulated engineering environments where cross-functional teams work to bring Class III medical devices toward market approval. The work could involve partnering with engineering, quality assurance and clinical teams to navigate regulatory requirements, prepare submissions and maintain compliance throughout the product lifecycle. You could have scope to influence regulatory strategy and support the timely progression of programmes through key regulatory milestones.

Typical role overview

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

What you would do

Typical responsibilities could include:

• Developing and executing regulatory strategies aligned with product timelines and market access goals
• Preparing and managing regulatory submissions, including 510(k)s, PMA documentation and CE mark applications
• Ensuring compliance with ISO 13485, IEC 62304 and other applicable standards and regulations
• Liaising with regulatory bodies such as the FDA and MHRA to address questions and support approval pathways
• Coordinating with engineering, quality and clinical teams to gather technical data and documentation
• Maintaining regulatory intelligence and tracking changes in regulatory requirements
• Supporting post-market compliance and surveillance activities
• Contributing to the development and maintenance of regulatory documentation and quality management systems

What you could bring

Most roles of this type require the following:

• Bachelor's degree in Business, Life Sciences, Engineering or a related discipline
• 3–5 years of regulatory affairs experience within medical device development
• Working knowledge of ISO 13485 and IEC 62304 standards
• Experience with Class III medical device submissions, such as 510(k) or PMA pathways
• Familiarity with FDA and/or European regulatory requirements
• Strong written and verbal communication skills
• Ability to manage multiple workstreams and coordinate across functions
• Authorization to work in the United Kingdom

Nice-to-have:

• Certified Compliance Professional (CCP) certification
• Experience with post-market surveillance and vigilance reporting
• Knowledge of clinical evaluation reports and technical file development

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 innovative medical devices to patients
• Exposure to the full regulatory lifecycle, from strategy through market approval
• Opportunity to build expertise in complex regulatory pathways and standards
• Potential for contract extension or transition to permanent roles, depending on programme needs and performance
• Working within a structured regulatory and quality environment
• Collaboration with experienced cross-functional teams
• Professional development opportunities in compliance and regulatory strategy

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.