Medical Device Business Analyst jobs

Regulatory Specialist publications in this area could focus on supporting the development and compliance of medical devices through their lifecycle, with particular emphasis on Class III devices subject to stringent regulatory frameworks including ISO 13485 and IEC 62304. This is an opportunity to register your interest in future Regulatory Specialist roles where you could help guide products through complex approval pathways and maintain compliance with evolving regulatory standards.

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 Specialist opportunities within medical device compliance and regulatory affairs. Roles of this type may sit within organisations advancing Class III medical devices, where regulatory excellence directly supports patient safety and product market access.

The work could involve collaborating with cross-functional teams including engineering, quality assurance and clinical affairs to navigate regulatory pathways, maintain compliance documentation, and respond to regulatory inquiries. You could contribute to submissions, regulatory strategy and the ongoing management of post-market compliance obligations.

Typical role overview

• Location: Edinburgh, City of Edinburgh, Scotland
• Type: Contract · Full-time
• Rate: £450–550 per day
• Domain: Class III Medical Device · Regulatory Compliance · ISO 13485 · IEC 62304

What you would do

Typical responsibilities could include:

• Supporting the preparation and submission of regulatory documentation for Class III medical device approvals
• Assisting with the development and maintenance of regulatory strategy aligned to product lifecycle stages
• Coordinating with engineering, quality and clinical teams to ensure regulatory compliance throughout development
• Maintaining and updating regulatory intelligence, including tracking changes to ISO 13485, IEC 62304 and relevant approval pathways
• Contributing to post-market compliance activities, including adverse event reporting and periodic safety updates
• Supporting responses to regulatory queries and inspection findings
• Documenting regulatory decisions and maintaining compliance records

What you could bring

Most roles of this type require the following:

Must-have

• Bachelor's degree in Business or a related field
• Working knowledge of ISO 13485 (Medical Device Quality Management Systems) and IEC 62304 (Medical Device Software Lifecycle Processes)
• Understanding of Class III medical device regulatory pathways and approval processes
• Strong written and verbal communication skills
• Ability to work collaboratively across engineering, quality and clinical functions
• Attention to detail and ability to manage complex compliance documentation

Nice-to-have

• Certified Compliance Professional (CCP) or equivalent regulatory certification
• Experience with regulatory submissions and post-market surveillance
• Familiarity with relevant approval bodies (FDA, MHRA, CE marking requirements)
• Experience in a contract or project-based regulatory role

What roles of this type could offer

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

• Exposure to high-impact medical device development where regulatory decisions directly influence patient safety
• Opportunity to develop specialist knowledge in Class III device compliance and regulatory strategy
• Structured progression and mentorship within a collaborative regulatory function
• Contract-based flexibility with clear scope and deliverables
• Potential involvement in multiple product programmes across different therapeutic areas
• Professional development opportunities aligned with regulatory and compliance certifications

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.