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Regulatory Affairs
Scientific Supplier
Regulatory & Compliance
£ Contact Bailey
Cambridge
£40,000 - £50,000
Role Overview
We are recruiting a Regulatory Affairs Specialist to join a growing diagnostics organisation operating across the UK. This role sits within a small, collaborative regulatory team and offers broad exposure across IVD regulatory submissions and clinical trial activities.
You will work closely with the UK and US regulatory teams, this is an ideal opportunity for someone who enjoys working in a hands-on environment, taking ownership and wearing multiple hats.
No other candidates currently under consideration
Company Information
Regulatory Affairs Specialist – IVD
Location: Cambridge, UK (Office-based)
Contract: Permanent, Full-time
Start Date: ASAP
Role Requirements
Support and manage IVD regulatory submissions across the UK, EU, and potentially US markets
Prepare, compile, and submit regulatory documentation in line with: CE Marking, IVDR, UK regulatory requirements, ISO 13485 & ISO 9001
Support clinical trial activities, including:
Running and coordinating clinical trials
Analysing clinical data
Preparing and submitting clinical trial applications
Collaborate closely with cross-functional teams in a fast-paced, growing environment
Participate in regular internal regulatory meetings
Person Specifications
Required Experience & Background
We are open to candidates at different experience levels, including:
Essential: Experience within IVD Regulatory Affairs
Strong knowledge of: IVDR, CE Marking, UK approvals, ISO 13485 & ISO 9001 and experience preparing and submitting regulatory documentation
Desirable:
Molecular diagnostics background (beneficial but not essential)
Experience in any IVD discipline considered
FDA experience (nice to have)
MDR Regulatory Affairs experience may also be considered
Soft Skills
Strong team player
Proactive with good initiative
Effective problem-solving skills
High level of motivation and drive
Package
Salary: flexible depending on experience
Bonus: Performance-related bonus
Equity: Share options available after 1 year
Holiday: 20 days annual leave
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Locations
Bishop's Stortford
Bourne
Brentwood
Buckingham
Bury St Edmunds
Cambridge
Chelmsford
Clacton-on-Sea
Colchester
Ely
Felixstowe
Harlow
Harwich
Hertford
Hitchin
Ipswich
Milton Keynes
Newmarket
Newport Pagnell
Peterborough
Royston
Saffron Walden
Stamford
Stevenage
Sudbury
Thetford
Date Updated
17 Dec 2025
Job reference
75136
Categories
Full Time
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