Medical Device Product Specialist jobs

We are looking to build our regulatory affairs capabilities through a contract role focused on supporting medical device compliance and product lifecycle management. This is an opportunity to register your interest in future Regulatory Affairs positions where you could contribute to bringing compliant, safe medical devices to market.

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

About the opportunity

This contract position offers the chance to work within a regulated medical device environment, supporting the delivery of Class III medical devices through their development and commercialisation lifecycle. You could be based in Cambridge, Cambridgeshire, contributing to cross-functional teams managing product compliance, quality systems and regulatory submissions. The role would involve applying your knowledge of ISO 13485 and IEC 62304 standards to ensure products meet stringent safety and efficacy requirements before market release.

Typical role overview

• Location: Cambridge, Cambridgeshire, England
• Type: Contract · Full-time
• Rate: £450–550 per day
• Domain: Class III medical device · regulatory compliance · product lifecycle management

What you would do

Typical responsibilities could include:

• Supporting regulatory submissions and maintaining ongoing compliance documentation for Class III medical devices
• Assisting with quality management system (QMS) activities aligned to ISO 13485 and IEC 62304 requirements
• Contributing to design control and risk management processes during product development
• Liaising with cross-functional teams including engineering, quality and commercial to ensure regulatory requirements are met
• Maintaining regulatory intelligence and monitoring changes to applicable regulations and standards
• Preparing and reviewing technical files, dossiers and regulatory correspondence
• Supporting post-market surveillance and adverse event reporting processes

What you could bring

Most roles of this type require the following:

• Bachelor's degree in Business, life sciences, engineering or a related field
• Knowledge of ISO 13485 (Medical Device Quality Management Systems) and IEC 62304 (Medical device software lifecycle processes)
• Understanding of Class III medical device regulatory requirements and product lifecycle management
• Familiarity with regulatory frameworks and submission processes (such as CE marking, FDA or equivalent)
• Strong organisational and documentation skills
• Ability to work collaboratively across teams in a regulated environment
• Authorization to work in the United Kingdom

Nice-to-have:

• Certified Compliance Professional (CCP) or equivalent regulatory certification
• Prior experience supporting medical device submissions or regulatory inspections
• Knowledge of risk management standards such as ISO 14971

What roles of this type could offer

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

• The opportunity to contribute directly to products that improve patient safety and outcomes
• Exposure to the full product lifecycle within a regulated medical device environment
• Development of specialist regulatory and compliance expertise
• Potential for extension or transition into permanent regulatory roles, where supported by business need
• Professional development in quality systems, regulatory strategy and industry standards
• Access to a collaborative, in-person working environment with remote flexibility where available

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.