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- Tasks: Lead PMA submission documentation and collaborate on regulatory strategies.
- Company: Join a £100M backed start-up revolutionising neuromodulation devices.
- Benefits: Enjoy remote work, equity options, 27 days holiday, and private healthcare.
- Why this job: Be part of a groundbreaking project with high growth potential and impactful responsibilities.
- Qualifications: Experience with Class III medical devices and PMA submissions is essential.
- Other info: Monthly onsite meetings in Oxford to foster team collaboration.
The predicted salary is between 45000 - 50000 £ per year.
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) to 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.
Senior Regulatory Associate employer: CAPU Search
Contact Detail:
CAPU Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Associate
✨Tip Number 1
Familiarise yourself with the latest FDA regulations and guidelines related to Class III medical devices. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs community, especially those who have experience with PMA submissions. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your collaborative work across teams like R&D, Clinical, and Quality. Highlighting your ability to work cross-functionally will show that you can thrive in the dynamic environment of a start-up.
✨Tip Number 4
Research the company’s recent achievements and their neuromodulation device. Being able to speak knowledgeably about their products and goals during your conversations will set you apart as a candidate who is genuinely interested in their mission.
We think you need these skills to ace Senior Regulatory Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with Class III medical devices and PMA submissions. Use specific examples to demonstrate your involvement in regulatory affairs and collaboration with cross-functional teams.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your relevant experience with FDA processes and how you can contribute to the team’s success in bringing the neuromodulation device to market.
Highlight Relevant Skills: Emphasise skills that are crucial for the role, such as documentation management, regulatory strategy development, and teamwork. Be specific about your contributions to past projects and how they relate to the responsibilities of the Senior Regulatory Associate position.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential in regulatory affairs.
How to prepare for a job interview at CAPU Search
✨Showcase Your Class III Experience
Make sure to highlight your experience with Class III medical devices during the interview. Be prepared to discuss specific projects you've worked on, especially those involving PMA submissions, as this will demonstrate your relevant expertise.
✨Emphasise Team Collaboration
Since the role requires working across various teams like R&D, Clinical, and Quality, be ready to share examples of how you've successfully collaborated in the past. This will show that you can thrive in a cross-functional environment.
✨Familiarise Yourself with FDA Processes
Understanding FDA regulations and processes is crucial for this position. Brush up on your knowledge of FDA Q-Subs and other regulatory strategies, and be prepared to discuss how you've navigated these in previous roles.
✨Prepare Questions About the Company’s Growth
Given that the company has recently secured significant funding and is scaling quickly, prepare insightful questions about their growth strategy and future plans. This shows your genuine interest in the company and its mission.
