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Medical Devices Quality Manager jobs in Cambridge

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    • Experience with medical device quality management systems (QMS).
    • Involvement in bringing regulated medical devices to patients.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device regulations.
    • Ensuring compliance with ISO 13485, IEC 62304 and relevant Class III medical…
    • Proven experience in regulatory affairs or medical device compliance.
    • Domain: Class III medical device · regulatory and compliance affairs.
    • Driving improvements across quality processes, procedures and standards.
    • Maintaining quality standards and ensuring processes and procedures are being followed…
    • Practical experience in quality assurance, quality management, or a related manufacturing environment.
    • Good working knowledge of ISO 9001 requirements and…
    • Supporting the implementation of quality assurance frameworks and audit programmes.
    • Working collaboratively with operational managers and frontline teams to…
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    • This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
    • Experience implementing or improving quality systems, ideally with exposure to digital QMS solutions.
    • A strong understanding of quality management systems,…
    • Demonstrated knowledge of relevant quality standards and conformity assessment principles.
    • The role ensures that all certification activities are conducted in…
    • In-depth understanding of UKAS & ISO requirements and quality management systems.
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    • Proactively challenge existing quality controls to improve their effectiveness and the robustness of their deployment.
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    • Working closely with operational teams to promote quality and compliance across the business.
    • An understanding of quality systems, including deviations, CAPA…
    • Experience with quality management systems.
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    • Experience with quality management systems.
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Job Post Details

Regulatory Manager - job post

SThree
3.3 out of 5 stars
Cambridge
£450 - £550 a day - Fixed term contract
You must create an Indeed account before continuing to the company website to apply

Job details

Pay

  • £450 - £550 a day

Job type

  • Fixed term contract

Location

Cambridge

Full job description

Regulatory expertise is critical for bringing safe, compliant medical devices to market. This is an opportunity to register your interest in future Regulatory Manager positions where you could oversee regulatory strategies and ensure Class III medical device programmes meet stringent ISO 13485, IEC 62304 and FDA requirements.

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

About the opportunity

Roles of this type sit within regulated medical device environments where regulatory leadership shapes product development pathways and ensures compliance across design, manufacturing and commercialisation. The work could involve partnering with engineering, quality and clinical teams to navigate FDA design controls, maintain quality management systems, and guide devices through pre-market and post-market regulatory processes. This is a contract position based in Cambridge, Cambridgeshire, England.

Typical role overview

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

What you would do

Typical responsibilities could include:

  • Developing and executing regulatory strategies for Class III medical device programmes
  • Ensuring compliance with ISO 13485, IEC 62304 and relevant FDA requirements
  • Coordinating with engineering, quality and clinical teams to embed regulatory requirements into product development
  • Managing regulatory submissions, including pre-market notifications and post-market documentation
  • Overseeing quality management systems and design control processes
  • Maintaining stakeholder communication with regulatory authorities and internal leadership
  • Contributing to risk assessments and regulatory intelligence across the device portfolio

What you could bring

Most roles of this type require the following:

Must-have

  • Bachelor's degree in Business or related discipline
  • 3–5 years' experience in regulatory affairs or medical device compliance
  • Working knowledge of ISO 13485, IEC 62304 and Class III medical device pathways
  • Understanding of FDA design controls and pre-market/post-market processes
  • Strong stakeholder management and cross-functional collaboration skills
  • Authorization to work in the United Kingdom

Nice-to-have

  • Certified Compliance Professional (CCP) or equivalent certification
  • Experience with medical device quality management systems (QMS)
  • Familiarity with CSDR or other regulatory frameworks
  • Master's degree in regulatory science or related field

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 patients
  • Opportunity to develop deep expertise in Class III device pathways and FDA compliance
  • Exposure to cross-functional product development teams and strategic regulatory decision-making
  • Potential progression toward senior or specialist regulatory roles, where supported by role performance and business need
  • Contract flexibility with clear rate and location terms

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.

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