Medibeam
Regulatory Manager
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If you're a Regulatory Affairs professional who's tired of being the last sign off on someone else's decision rather than the person actually shaping it, this one's worth a look.
A UK manufacturer is hiring a Regulatory Affairs Manager to run the day to day of their regulatory function, reporting directly to CEO.
You'd own the technical files and design dossiers for Class III devices, manage complaint and adverse incident handling end to end, and act as one of the primary points of contact for notified bodies and competent authorities.
The remit reaches past the UK and Europe too.
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- You'd coordinate international submissions
- Support distributors and partners
- Keep product registrations current across multiple markets
So if you want regulatory breadth rather than a single geography, it's here.
You'll need at least four years in a medical device regulatory environment, a life science or engineering degree (or equivalent), and solid working knowledge of Class II requirements and above for the European market.
Experience in North America, South America or Asia Pacific markets is a bonus rather than a requirement.
Project leadership or people management experience matters too, someone who can develop a junior team member's confidence, not just complete their own workload.
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This is a methodical, detail led role. You'll need to:
- Make calls from incomplete information
- Hit agreed timescales
- Spot the knock on impact of a regulatory change before it bites the business somewhere else
Please note, this role predominantly is onsite, 4x per week at least for the first 9-12 months and the business can currently only accept people with the full right to work in the UK.
If you'd like to learn more, please apply and I will be in touch.
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