Quality Manager Medical Devices jobs in Cambridgeshire
- SThreeCambridge
- Prior experience supporting medical device submissions or regulatory inspections.
- Understanding of Class III medical device regulatory requirements and product…
- SThreeCambridge
- Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
- SThreeCambridge
- Experience supporting Class III medical device development or comparable regulated environments.
- Involvement in bringing regulated medical devices to market and…
- The One GroupCambridgeshire
- Life insurance
- Company pension
- On-site parking
- Driving improvements across quality processes, procedures and standards.
- Maintaining quality standards and ensuring processes and procedures are being followed…
- Capgemini SogetiCambridge
- Manage quality processes such as quality gates, audits, and process adherence activities.
- Strong working knowledge of ECSS / ESA standards and quality…
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- ALQUEST Technical RecruitmentCambridge
- The ATE Technical Lead will define test strategies, guide tester architecture decisions, lead tester bring-up, improve production quality and yield, and support…
- Capgemini EngineeringCambridge
- Manage quality processes such as quality gates, audits, and process adherence activities.
- Strong working knowledge of ECSS / ESA standards and quality…
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- SkanskaPeterborough
- Actively participate in the @one Alliance Quality Community to drive best practice and improvement of the quality process.
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View similar jobs with this employerPA ConsultingMelbourn- 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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View similar jobs with this employerPA ConsultingMelbourn- Significant experience (typically 8+ years) within medical device industry.
- Medical Devices: Advising on medical device quality and regulatory requirements,…
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- PA ConsultingMelbourn SG8
- Supplier quality and audit support.
- Building trusted relationships with clients, quality leaders, business stakeholders and regulators.
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- OSIESt. Neots PE19 8YP
- The first point of contact to the shop floor for product quality issues of mechanical fit, process quality and electronic component specification.
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- OSIESt. Neots PE19 8YP
- The first point of contact to the shop floor for product quality issues of mechanical fit, process quality and electronic component specification.
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- LGC AssureFordham
- Experience implementing or improving quality systems, ideally with exposure to digital QMS solutions.
- A strong understanding of quality management systems,…
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- Deep technical engineering experience, typically developed over 10+ years in the medical device sector, ideally with expertise in pharmaceutical injectable drug…
- Phillips MedisizeCambridge
- Laboratory testing - Perform laboratory test procedures and build medical device test samples.
- Phillips Medisize, a Molex company, collaborates with industry…
Regulatory Affairs Specialist
Job details
Pay
Job type
Full job description
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.