Regulatory Specialists play a crucial role in ensuring that medical devices and related products meet stringent safety, quality and compliance standards. This opportunity could involve working with Class III medical devices, navigating complex regulatory frameworks such as ISO 13485 and IEC 62304, and contributing to the delivery of life-changing technology to patients.

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 and compliance. Roles of this type may sit within quality, regulatory affairs or risk management functions at organisations advancing Class III medical devices toward market approval. The work could involve partnering across engineering, quality and operations to maintain regulatory compliance, support design controls, and guide products through FDA and international regulatory pathways.

Typical role overview

Location: Manchester, Greater Manchester, England
Type: Contract
Rate: £450–550 per day
Domain: Medical Device Regulatory Affairs · Class III devices · ISO 13485 and IEC 62304

What you would do

Typical responsibilities could include:

Supporting the preparation and maintenance of regulatory documentation, including design history files (DHF) and device master records (DMR)
Assisting with regulatory submissions and liaising with regulatory authorities such as the FDA and MHRA
Contributing to design control activities and supporting compliance with ISO 13485 and IEC 62304 requirements
Monitoring changes to regulatory requirements and advising on their impact on product portfolios
Coordinating with quality, engineering and operations teams to ensure regulatory alignment throughout product development
Supporting risk management and quality management system (QMS) activities
Preparing regulatory briefings and compliance reports for internal stakeholders

What you could bring

Most roles of this type require the following:

Bachelor's degree in Business, Life Sciences, Engineering or a related field
Working knowledge of ISO 13485, IEC 62304 and FDA design controls
Experience with Class III medical device regulatory affairs or equivalent compliance environment
Understanding of regulatory frameworks including MDR, PMCF and post-market surveillance
Strong written and verbal communication skills
Attention to detail and ability to manage complex documentation
Familiarity with regulatory databases, document management systems and Microsoft Office

Nice-to-have:

Certified Compliance Professional (CCP) certification
3+ years' regulatory affairs or quality assurance experience
Knowledge of international regulatory pathways beyond the US and UK

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 cutting-edge medical device development and the opportunity to contribute to products that improve patient outcomes
Development of regulatory expertise and compliance knowledge
Collaboration with multidisciplinary teams across engineering, quality and commercial functions
Potential progression toward senior regulatory or quality leadership roles
Contract flexibility and the opportunity to work across multiple projects and organisations
Professional development through regulatory training and industry engagement

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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