Regulatory Specialists play a central role in ensuring that medical device development programmes meet rigorous compliance standards and bring safe, effective products to market. This is an opportunity to register your interest in future Regulatory Specialist positions where you could guide organisations through the complexities of medical device regulation, from design controls through to market approval.

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

About the opportunity

Roles of this type sit within cross-functional teams working on Class III medical device programmes, where regulatory strategy directly influences product timelines and market access. You could work alongside engineering, quality and clinical teams to navigate ISO 13485, IEC 62304 and FDA design control requirements. The position offers scope to contribute to regulated delivery, manage regulatory submissions and support programmes moving towards launch in heavily controlled environments.

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 · ISO 13485 & IEC 62304

What you would do

Typical responsibilities could include:

Supporting regulatory strategy and submission planning for Class III medical device programmes
Managing interactions with regulatory bodies, including FDA and EMA, on compliance matters
Coordinating design control documentation, traceability and regulatory records
Ensuring compliance with ISO 13485 and IEC 62304 throughout product development
Contributing to risk assessments and regulatory impact analyses
Liaising with engineering, quality and clinical functions to maintain regulatory alignment
Maintaining regulatory intelligence and tracking changes to applicable standards

What you could bring

Most roles of this type require the following:

3–7 years' experience in regulatory affairs, medical device compliance or related regulatory function
Working knowledge of ISO 13485, IEC 62304 and Class III medical device pathways
Familiarity with FDA design control requirements and submission processes
Bachelor's degree in a business-related field or equivalent professional experience
Strong stakeholder communication and cross-functional coordination
Attention to detail and ability to manage complex regulatory documentation
Authorization to work in the United Kingdom

Nice-to-have

Certified Compliance Professional (CCP) or equivalent regulatory certification
Experience with implantable or invasive device programmes
Exposure to post-market surveillance or pharmacovigilance

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 shape the regulatory pathway of innovative medical devices reaching patients
Exposure to end-to-end device development within a highly regulated environment
Potential to develop deeper expertise in FDA and EMA submission strategies
Flexible contract engagement with scope to transition or extend based on programme needs
Access to professional development in medical device regulation and compliance standards

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.