Senior Regulatory Affairs Associate – Class III Devices | PMA Submissions | Remote + Monthly Onsite in Oxford | Equity + £100M Backed Start-up
Our client is looking for a Senior Regulatory Affairs Associate to join their Regulatory team and help take a breakthrough neuromodulation device through PMA submission and into the market.
They’ve just secured $100 million in Series A funding following successful first-in-human trials and are scaling fast, with multiple EU studies underway and an IDE trial planned for 2026.
🔍 What we’re looking for:
* Proven Class III medical device experience
* PMA submission involvement (can be collaborative, not necessarily owned solo)
* Comfort working across teams (R&D, Clinical, Quality)
* Experience with FDA
🧠 What you’ll be doing:
* Leading on PMA submission documentation
* Collaborating on validation, chemical characterisation, GLP studies, IFUs, and more
* Playing a key role in FDA Q-Subs and cross-functional regulatory strategy
* Shaping standards management and supporting the IDE study documentation
💼 The package:
* £45,000-£50,000 per annum
* Equity scheme in a business on the rise
* Remote-first, with monthly travel (expensed) Oxford
* 27 days holiday + bank holidays
* Private healthcare (including optical & dental), 3% pension, income protection, 4x life cover
This is a high-impact opportunity to shape a high-growth regulatory function, work closely with the VP, and genuinely own part of something groundbreaking.