Medibeam
Regulatory Specialist
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Regulatory Affairs Associate
If you’ve built your foundations in Regulatory Affairs and now want more ownership of submissions, technical documentation, and IVDR work, then I may have your next role.
I’m working with an established diagnostics business looking for a Regulatory Affairs Specialist to join their team in Cambridge, spanning new registrations, IVDR transition, technical documentation, and post-market activity.
What you’ll be working on:
You’ll support the registration and ongoing compliance of IVD products across multiple international markets.
Your remit will include:
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- Supporting new product registrations and global regulatory submissions
- Preparing and maintaining regulatory and technical documentation
- Supporting the transition of legacy products from IVDD to IVDR
- Contributing to PMS and lifecycle management for existing IVD products
- Working across regulated product portfolios
- Supporting QMS and wider regulatory compliance activities
- Helping improve the efficiency of regulatory processes and systems
What I’m looking for
You’ll already have some hands-on Regulatory Affairs experience within IVDs, diagnostics, or a closely related medical device environment.
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Ideally, you’ll bring exposure to:
- Regulatory submissions / product registrations
- IVDR and/or IVDD
- Technical documentation
- Post market surveillance
- Working within an ISO 13485 QMS
You don’t need to have done everything. What matters more is that you understand the fundamentals and want to build broader, hands-on regulatory experience rather than stay in a narrow remit.
Salary: Up to £45,000
Location: Cambridge, onsite
Interested? Apply directly or message me for a confidential conversation.
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