Regulatory Specialist in Stockport

Regulatory Specialist

Class I and IIa | UK-based | Hybrid (2 to 3 days onsite)

If you’re tired of being boxed into a tiny corner of Regulatory Affairs, this is the role that finally gives you the ability to work across it all.

A long established Medical Device manufacturer (40+ years in business) is growing fast and looking for a Regulatory Specialist who wants ownership, variety, and the chance to shape how things are done as they scale across Europe.

What’s in it for you

• Ownership of meaningful end to end regulatory work

• A company already MDR certified with zero audit findings

• Exciting new product development coming through the pipeline

• Real influence over technical documentation, processes and compliance direction

• Hybrid working with flexibility (2 to 3 days onsite)

• Clear progression and development opportunities as the business scales

• Stability and backing from a global group, without losing the small company feel

What you’ll be working on

• MDR maintenance across the product range

• Building and updating technical files from scratch

• Supporting new product development and EU expansion projects

• Contributing to biocompatibility inputs & CER updates

• Managing global registrations and renewals (EU focus, plus ROW exposure)

• Leading PMS activities, product review meetings and contributing to complaints decisions

• Handling vigilance/recall actions, ensuring timelines and reporting requirements are met

What they’re looking for

Someone who enjoys autonomy, likes getting stuck into all aspects of regulatory and is confident in their ability. This isn\’t a position where you will be hand held. They\’re looking for someone to come in and know the landscape well enough to hold your own.

If you’ve ever felt like a tiny cog in a giant RA team, you won’t here.

This is a small, close knit environment where everyone knows each other and your work actually matters.

To be considered, you must:

• Be UK based

• Be happy to be onsite 2 to 3 days per week

• Have experience working within Medical Device regulations (4+ years)

Please submit your CV if you\’d like to be considered.