Regulatory Specialist

Medibeam; Cambridge; On-site; GBP 41,000 - 50,000; Full time

Job summary

Medibeam in Cambridge is seeking a Regulatory Affairs Specialist to own regulatory submissions and IVDR/IVDD activities for IVD products. You will prepare regulatory and technical documentation and help manage lifecycle activities across multiple markets.

The role focuses on ensuring ongoing compliance within an ISO 13485 QMS environment, supporting PMS and cross-portfolio regulatory work, and driving process improvements to enhance efficiency. This is a site-based position in Cambridge.

Qualifications

• Hands-on Regulatory Affairs experience within IVDs, diagnostics or related medical device environment.
• Experience with regulatory submissions and product registrations.
• Exposure to IVDR and/or IVDD regimes.
• Experience working within an ISO 13485 QMS.

Responsibilities

• Support new product registrations and global regulatory submissions.
• Prepare and maintain regulatory and technical documentation.
• Support the transition of legacy products from IVDD to IVDR.
• Contribute to PMS and lifecycle management for existing IVD products.
• Work across regulated product portfolios.
• Support QMS and broader regulatory compliance activities.
• Help improve the efficiency of regulatory processes and systems.

Skills

Regulatory submissions

IVD regulation

Technical documentation

QMS experience

Tools

ISO 13485

Job description

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