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    • Regulatory Specialists play a vital role in guiding medical device programmes through complex compliance landscapes.
    • What roles of this type could offer.
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biomedical scientist
Regulatory Specialist
SThree
·
3.3
Cambridge
£450 - £550 a day
Full-time

Job details

Here’s how the job details align with your profile.

Pay

£450 - £550 a day

Job type

Full-time

Full job description

Regulatory Specialists play a vital role in guiding medical device programmes through complex compliance landscapes. This opportunity could involve working with Class III medical device development teams to ensure adherence to ISO 13485, IEC 62304 and FDA design controls, supporting the delivery of regulated products that reach patients safely and on time.

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 development, roles that could support the successful navigation of regulatory pathways for life-changing technology. You could be based in Cambridge, Cambridgeshire, working on a contract basis (£450–550 per day).

Roles of this type may sit within collaborative engineering teams, partnering with cross-functional stakeholders including quality, operations and clinical affairs to maintain regulatory compliance throughout new product development. The work could involve translating regulatory requirements into actionable delivery plans, coordinating submissions and supporting teams in understanding and applying complex regulatory frameworks.

Typical role overview

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

What you would do

Typical responsibilities could include:

  • Supporting the development and maintenance of regulatory strategies for Class III medical device programmes
  • Coordinating regulatory submissions and maintaining compliance documentation under ISO 13485 and IEC 62304
  • Advising engineering and operations teams on design control requirements and FDA expectations
  • Managing regulatory timelines and milestone tracking for product development programmes
  • Liaising with quality and clinical teams to ensure regulatory alignment across cross-functional workstreams
  • Contributing to the identification and mitigation of regulatory risks throughout the product lifecycle
  • Supporting continuous improvement of regulatory processes and documentation systems

What you could bring

Most roles of this type require the following:

  • 3+ years' experience in regulatory affairs, medical device compliance or related regulatory role
  • Working knowledge of ISO 13485, IEC 62304 and FDA design controls
  • Experience supporting Class III medical device development or comparable regulated environments
  • Bachelor's degree in Business or a related discipline
  • Strong stakeholder management and cross-functional communication skills
  • Excellent attention to detail and ability to manage complex compliance documentation
  • Authorization to work in the United Kingdom

Nice-to-have

  • Certified Compliance Professional (CCP) or equivalent certification
  • Experience with regulatory submissions and FDA interactions
  • Knowledge of post-market compliance and vigilance requirements

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 regulated medical devices to market and supporting patient outcomes
  • Exposure to complex regulatory frameworks and the opportunity to build deep compliance expertise
  • Collaborative working environment with experienced engineering and quality teams
  • Potential for contract extension and progression within regulated product development
  • Professional development in a specialized and evolving regulatory landscape
  • Flexible, project-based engagement with scope to contribute directly to programme success

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.

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