Biotechnology jobs in Limpsfield
- SThreeLondon
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- Pwc UKLondon SE1
- As a senior manager in Strategy&’s Pharma Life Sciences group, you are a leading thought-partner to clients, solving problems and running the day-to-day…
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- GlaxoSmithKlineLondon
- The AI/ML Controllable Biology Team applies machine learning and AI methods to biological networks and sequence data from large-scale human genetic, functional…
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- GlaxoSmithKlineLondon
- We identify and provide recommendations on key questions informing the evolution of GSK’s R&D strategy.
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- SThreeLondon
- Regulatory Specialists in this field play a crucial role in ensuring that medical devices meet stringent compliance standards and reach patients safely.
- TalentmarkBurgess Hill
- Work from home
- This role is hybrid, based in Burgess Hill, West Sussex, with the flexibility to work from home in line with business needs (2 days per week).
- AECOMLondon
- This is a strategic leadership role suited to someone with a proven track record delivering medium–large, technically complex new‑build and refurbishment Life…
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- Capgemini SogetiLondon
- We build trusted partnerships with senior stakeholders by translating business needs into technology solutions and measurable outcomes.
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- PA ConsultingLondon SW1E
- Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation.
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Regulatory Affairs
Job details
Pay
Job type
Full job description
Regulatory Affairs roles in this space could focus on navigating complex compliance landscapes within medical device development, ensuring that innovative products meet stringent standards whilst moving through approval pathways efficiently. A central theme could be managing regulatory strategy, submissions and stakeholder engagement across cross-functional teams.
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 Affairs opportunities within medical device development, roles that could support the safe and compliant delivery of life-changing technology to patients.
Roles of this type may sit within a collaborative, regulated environment at a business advancing medical devices toward market approval. The work could involve partnering across engineering, quality and operations to manage regulatory submissions, maintain compliance with ISO 13485 and IEC 62304, and coordinate with regulatory bodies on behalf of Class III medical devices. You could have scope to influence regulatory strategy and support the timely progression of products through approval pathways.
Typical role overview
- Location: London, Greater London, England
- Type: Contract · Full-time
- Rate: £450–550 per day
- Domain: Medical device · Regulatory Affairs · Compliance
What you would do
Typical responsibilities could include:
- Managing regulatory submissions and maintaining ongoing compliance with FDA, EMA and UK regulatory requirements
- Coordinating regulatory strategy across engineering, quality and operations teams
- Preparing and submitting regulatory dossiers, including technical files and summary documents for Class III devices
- Maintaining compliance with ISO 13485, IEC 62304 and other relevant medical device standards
- Supporting post-market surveillance and adverse event reporting
- Liaising with regulatory authorities and responding to regulatory enquiries
- Documenting regulatory decisions and maintaining audit trails
- Contributing to process improvements in regulatory workflows
What you could bring
Most roles of this type require the following:
- 3–5 years' experience in regulatory affairs within the medical device sector
- Demonstrable knowledge of ISO 13485, IEC 62304 and Class III medical device regulation
- Experience preparing regulatory submissions for FDA, EMA or UK regulatory pathways
- Strong understanding of GxP principles and quality management systems (QMS)
- Bachelor's degree in a related field such as Business, Engineering, Life Sciences or equivalent
- Excellent written and verbal communication skills
- Ability to manage multiple regulatory projects and meet submission deadlines
- Authorization to work in the United Kingdom
Nice-to-have:
- Certified Compliance Professional (CCP) or equivalent regulatory certification
- Experience with post-market surveillance and vigilance reporting
- Familiarity with regulatory software platforms and submission management systems
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 influence regulatory pathways for medical devices that could reach patients
- Exposure to cross-functional collaboration across engineering, quality and commercial teams
- Scope to develop deeper expertise in medical device regulation and compliance frameworks
- Professional development and potential progression to senior regulatory positions
- Contract-based flexibility with a daily rate of £450–550, dependent on experience and expertise
- The chance to work on innovative medical device projects at a regulated business
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.