Regulatory Specialist

Job Description If youre 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 variety, and the chance to shape how things are done as they scale their product portfolio.Whats in it for you Ownership of meaningful end to end regulatory work Exciting new product development coming through the pipeline Real influence over technical documentation, processes and compliance direction Hybrid working with flexibility (3 days onsite) Stability and backing from a global group, without losing the small company feelWhat youll be working on MDR compliance across a high classification and varied product range New Product Development NPD, 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 (US and 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 metWhat theyre looking forNow, I know this is a big ask, looking for someone that ticks all areas of Regulatory Affairs, so that isn't the case. We don't need it all! Ideally the client would be looking for a solid understanding of technical file compilation for MDR compliance and exposure to product submissions at a minimum.They definitely need someone who enjoys autonomy and likes getting stuck into all aspects of regulatory. 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 youve ever felt like a tiny cog in a giant RA team, you wont 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 with the right to work in the UK Be happy to be onsite in Sheffield 3 days per week Have experience working within Medical Device regulations (4+ years)Please submit your CV if you'd like to be considered.

Created: 2026-03-07