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:
- 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.
Ideally, you’ll bring exposure to:
- Regulatory submissions / product registrations
- IVDR and/or IVDD
- Technical documentation
- 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
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Regulatory Specialist in Cambridge employer: Medibeam
Medibeam is an excellent employer for those looking to grow within the MedTech industry, offering a supportive culture that prioritises employee development and training. With a well-established ISO 13485 quality management system, employees can expect to gain invaluable experience and skills in QA processes while enjoying the flexibility of a hybrid work model after the initial onboarding period. The company's commitment to fostering talent makes it an ideal place for individuals eager to advance their careers in a meaningful and rewarding environment.
