Regulatory Specialist

Regulatory Affairs Associate

Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.

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
• 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? xwzovoh Apply directly or message me for a confidential conversation.