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    • Understanding of software validation and cybersecurity requirements in medical devices.
    • Experience supporting Class III medical device submissions or…
    • Potential to develop specialist expertise in medical device regulations.
    • Ensuring product compliance with ISO 13485, IEC 62304 and relevant medical device…
    • Potential to develop specialist expertise in medical device regulations.
    • Ensuring product compliance with ISO 13485, IEC 62304 and relevant medical device…
    • Understanding of software validation and cybersecurity requirements in medical devices.
    • Experience supporting Class III medical device submissions or…
    • Potential to develop specialist expertise in medical device regulations.
    • Ensuring product compliance with ISO 13485, IEC 62304 and relevant medical device…
  • View similar jobs with this employer
    • Advanced certifications in quality assurance or medical device compliance.
    • Executing system validation testing across Class III medical device development.
    • Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
    • Advanced certifications in quality assurance or medical device compliance.
    • Executing system validation testing across Class III medical device development.
    • Advanced certifications in quality assurance or medical device compliance.
    • Executing system validation testing across Class III medical device development.
    • Advanced certifications in quality assurance or medical device compliance.
    • Executing system validation testing across Class III medical device development.
    • Potential to develop specialist expertise in medical device regulations.
    • Ensuring product compliance with ISO 13485, IEC 62304 and relevant medical device…
    • Understanding of software validation and cybersecurity requirements in medical devices.
    • Experience supporting Class III medical device submissions or…
    • Understanding of software validation and cybersecurity requirements in medical devices.
    • Experience supporting Class III medical device submissions or…
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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…

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Job Post Details

Regulatory Affairs Specialist - job post

SThree
3.3 out of 5 stars
Cambridge
£250 - £750 a day - Fixed term contract
You must create an Indeed account before continuing to the company website to apply

Job details

Pay

  • £250 - £750 a day

Job type

  • Fixed term contract

Location

Cambridge

Full job description

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 Regulatory Affairs roles, positions that could support organisations in navigating complex regulatory environments and ensuring compliance across their operations. Roles of this type may sit within dynamic, collaborative teams where regulatory expertise directly influences product development, market access and organisational risk management.

What you would do

Typical responsibilities could include:

  • Supporting the development and maintenance of regulatory strategies aligned with product lifecycle and market requirements
  • Preparing and submitting regulatory documentation to relevant authorities, including technical files, dossiers and compliance reports
  • Monitoring regulatory changes and advising internal teams on implications for current and future products
  • Coordinating with cross-functional teams including quality, engineering, clinical and commercial functions
  • Maintaining regulatory intelligence and competitor tracking to support strategic planning
  • Supporting internal audits and regulatory inspections to ensure ongoing compliance
  • Contributing to the interpretation and implementation of regulatory standards such as ISO 13485, IEC 62304 and requirements for Class III medical devices
  • Liaising with notified bodies, competent authorities and regulatory consultants as needed

What you could bring

Most roles of this type require the following:

  • Bachelor's degree in Business, Life Sciences, Engineering or related discipline
  • 3-5 years' experience in regulatory affairs, quality assurance or compliance within a regulated environment
  • Demonstrable knowledge of ISO 13485 (Medical Device Quality Management Systems) and IEC 62304 (Medical Device Software Lifecycle Processes)
  • Experience supporting Class III medical device submissions or equivalently complex regulatory pathways
  • Strong written and verbal communication skills, with the ability to translate complex regulatory requirements for diverse audiences
  • Proficiency in interpreting regulatory guidance documents and building compliant documentation
  • Organised approach to managing multiple regulatory projects and deadlines
  • UK-based or willing to work across UK locations on a nationwide basis

Nice-to-have:

  • Certified Compliance Professional (CCP) certification or equivalent
  • Experience with regulatory information management systems
  • Knowledge of post-market surveillance and adverse event reporting
  • Understanding of software validation and cybersecurity requirements in medical devices

What roles of this type could offer

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

  • Opportunity to influence product safety, efficacy and market access through rigorous regulatory oversight
  • Exposure to the full product lifecycle from development through commercialisation
  • Scope to develop deep expertise in regulatory frameworks and emerging compliance requirements
  • Potential for progression toward senior regulatory or compliance leadership roles
  • Collaborative working environment with multidisciplinary teams across quality, engineering and commercial functions
  • Flexibility and autonomy in managing regulatory projects and stakeholder relationships
  • Day rate typically ranging from £250–280 per day through to £750 per day, dependent on experience and contract scope

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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