Senior Regulatory Affairs Specialist – 12-Month FTC | Remote | £55,000–£60,000
We’re recruiting on behalf of a growing medical device company for a Senior RA Specialist to cover maternity leave, with a strong likelihood of becoming a permanent role.
This is a broad, hands-on position sitting within a collaborative regulatory affairs team. You’ll be picking up change control, submissions, competent authority and notified body correspondence, PMS reporting, and mentoring junior team members. The company is in an exciting phase as MDR certification is incoming for one of their brands, which means plenty of meaningful work ahead.
What the role involves:
Regulatory submissions across FDA 510(k), CE Mark, UKCA, Health Canada and international markets. Change control support. Lifecycle maintenance including PMS data collection and PSUR writing. Biocompatibility reviews. Representing RA in cross-functional meetings. Being a go-to resource for the wider team.
What they’re looking for:
4–7 years in medical device regulatory affairs. Solid working knowledge of EU MDR, ISO 13485, FDA QSR. Someone who’s worked across a broad remit — ideally from a small or mid-size company background where you’ve had to turn your hand to everything. FDA experience is a plus but not essential.
More than anything, they want someone who gets stuck in. Takes initiative. Works well remotely. Keeps people in the loop without being chased. If you’re the type who sees something that needs doing and just does it — this will suit you.
The details:
12-month fixed-term contract, fully remote. £55,000–£60,000 depending on experience. July/August start preferred, with a thorough handover before the person you’re covering goes on leave.
Real potential to go permanent and this is budgeted as a headcount addition for next year.
If this sounds like you, apply below.
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