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- Tasks: Join a collaborative team to shape AI-enabled medical devices and engage with regulators.
- Company: Innovative UK company at the forefront of AI technology in healthcare.
- Benefits: Competitive salary, remote work flexibility, and opportunities for professional growth.
- Other info: Remote role with occasional on-site meetings for collaboration.
- Why this job: Make a real impact in the exciting field of AI and medical devices.
- Qualifications: 5+ years in regulatory affairs with hands-on FDA experience required.
The predicted salary is between 50000 - 60000 £ per year.
Are you a regulatory professional with hands-on FDA experience and a genuine interest in AI-enabled medical devices? Our client is looking for a Regulatory Affairs Officer to join a small, collaborative team working on cutting-edge AI software. This is not a tick-box compliance role; you will be embedded in product development, working directly with engineering, clinical, and AI/ML teams to bring genuinely novel technology to market. This is a UK company and you must have the right to work in the UK.
What you’ll be doing:
- Authoring and maintaining technical files for AI-enabled SaMD submissions across the US, EU, and UK
- Supporting FDA pre-submissions and 510(k) activities — you’ll have real ownership here
- Advising internal teams on regulatory considerations for new features and changes
- Contributing to risk management, PMS, clinical evaluation, and QMS activities
- Engaging directly with regulators, notified bodies, and auditors
What we’re looking for:
- 5+ years in medical device regulatory affairs
- Practical US regulatory experience — pre-subs, 510(k), FDA interaction (non-negotiable)
- Exposure to software or embedded software devices (SaMD, IVD, combination products all considered)
- Knowledge of MDR/IVDR and UK regulations a strong plus
- Interest in AI regulation (EU AI Act, cybersecurity for SaMD) welcomed
- Degree in a relevant scientific or technical field
The role is predominantly remote but they would like some on-site presence — If you’re within an hour of the office you might come in every couple of weeks for a day. If you’re further away, audits and quarterly meetings are the main touchpoints.
Salary: £50–60k. There may be some flexibility for the right person.
Regulatory Affairs Officer employer: CAPU Search
Contact Detail:
CAPU Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those with FDA experience. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Show off your expertise! Prepare to discuss your hands-on experience with AI-enabled medical devices during interviews. Bring examples of how you've contributed to product development and regulatory submissions.
✨Tip Number 3
Stay updated on regulations! Brush up on the latest in MDR/IVDR and the EU AI Act. Being knowledgeable about current trends will impress potential employers and show you're genuinely interested in the field.
✨Tip Number 4
Apply through our website! We make it easy for you to find roles that match your skills. Plus, it shows you're serious about joining our team and helps us keep track of your application.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Show Your Passion for AI: When you're writing your application, let your enthusiasm for AI-enabled medical devices shine through. We want to see that you’re not just ticking boxes but genuinely excited about the technology and its potential impact.
Highlight Relevant Experience: Make sure to emphasise your hands-on FDA experience and any specific projects you've worked on in regulatory affairs. We love seeing how your background aligns with what we do, so don’t hold back!
Tailor Your Application: Don’t send a generic application! Take the time to tailor your CV and cover letter to reflect the job description. Mention your familiarity with MDR/IVDR and UK regulations if you have it, as it’ll make you stand out to us.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. Plus, it’s super easy!
How to prepare for a job interview at CAPU Search
✨Know Your Regulations
Brush up on your knowledge of FDA regulations, especially around pre-submissions and 510(k) processes. Be ready to discuss how your hands-on experience aligns with the requirements of the role, as this will show you’re not just familiar with the theory but have practical insights to offer.
✨Showcase Your Collaboration Skills
Since this role involves working closely with engineering, clinical, and AI/ML teams, prepare examples that highlight your ability to collaborate effectively. Think of specific projects where you’ve successfully worked in a team setting to bring a product to market.
✨Demonstrate Your Interest in AI
Given the focus on AI-enabled medical devices, it’s crucial to express your genuine interest in this area. Familiarise yourself with current trends and regulations related to AI in healthcare, and be prepared to discuss how you see these impacting regulatory affairs.
✨Prepare for Engaging Conversations
You’ll be engaging directly with regulators and auditors, so practice articulating your thoughts clearly and confidently. Prepare questions that demonstrate your understanding of the regulatory landscape and show that you’re proactive about compliance and quality management.