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 variety, and the chance to shape how things are done as they scale their product portfolio.
What’s 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 feel
What you’ll 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 met
What they’re looking for
Now, 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 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 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.
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