Regulatory Specialist

Job Description

Regulatory Specialists in this field play a crucial role in ensuring that medical devices meet stringent compliance standards and reach patients safely. This contract opportunity could involve navigating complex regulatory frameworks, managing documentation through product lifecycle stages, and collaborating with cross-functional teams to support device approval and market entry. 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 positions within medical device compliance and risk management. Roles of this type may sit within organisations advancing Class III medical devices through regulated pathways, working to ensure that products meet ISO 13485, IEC 62304 and other applicable technical standards. The work could involve partnering with engineering, quality and operations teams to maintain compliance documentation, support regulatory submissions, and manage post-market activities. You could contribute to bridging the gap between product development and regulatory requirements, with scope to develop your expertise in medical device regulation. Typical role overview Location: London, Greater London, England Type: Contract • Full-time Rate: £450-550 per day Domain: Class III Medical Device • Regulatory Compliance • Risk Management What you would do Typical responsibilities could include: Supporting the preparation and maintenance of regulatory documentation across device lifecycle stages Assisting with regulatory submissions and interactions with notified bodies or regulatory authorities Contributing to risk management activities, including hazard analysis and compliance mapping Reviewing design and quality documentation for regulatory alignment under ISO 13485 and IEC 62304 Supporting post-market surveillance activities and adverse event reporting processes Collaborating with engineering and quality teams to ensure regulatory requirements are integrated into product development Maintaining current knowledge of regulatory changes and industry guidance relevant to the device classification and market What you could bring Most roles of this type require the following: Must-have Bachelor's degree in Business, Life Sciences, Engineering or a related field 2-5 years' experience in regulatory affairs, quality assurance or compliance within medical device or pharmaceutical environments Working knowledge of ISO 13485, IEC 62304 and Class III medical device regulatory pathways Understanding of risk management principles and documentation standards Strong written and verbal communication skills Authorization to work in the United Kingdom Nice-to-have Certified Compliance Professional (CCP) certification Experience with notified body submissions or regulatory authority interactions Familiarity with quality management systems and regulatory change management Experience in post-market surveillance or adverse event handling 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 the full lifecycle of regulated medical device development and compliance Opportunity to develop deeper expertise in regulatory frameworks and standards Potential to work on products that contribute to patient safety and healthcare outcomes Collaboration with experienced regulatory and quality professionals Contract flexibility and the ability to support multiple projects or organisations Professional development opportunities within the compliance and regulatory field 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. TPBN1_UKTJ