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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, flexible remote work, and opportunities for professional growth.
- Other info: Dynamic role with a focus on innovation and 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 in Nottingham employer: CAPU Search
Contact Detail:
CAPU Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer in Nottingham
✨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 industry trends! Familiarise yourself with the latest regulations, especially around AI and medical devices. This knowledge will not only impress interviewers but also show your genuine interest in the field.
✨Tip Number 4
Apply through our website! We love seeing candidates who are proactive. Plus, it gives you a chance to showcase your enthusiasm for joining our collaborative team working on cutting-edge technology.
We think you need these skills to ace Regulatory Affairs Officer in Nottingham
Some tips for your application 🫡
Show Off Your Experience: Make sure to highlight your hands-on FDA experience and any relevant regulatory affairs roles you've had. We want to see how your background aligns with the needs of the role, so don’t hold back!
Tailor Your Application: Don’t just send a generic CV and cover letter. Take the time to tailor your application to the specific job description. Mention your interest in AI-enabled medical devices and how you can contribute to our innovative team.
Be Clear and Concise: When writing your application, keep it clear and to the point. We appreciate straightforward communication, so avoid jargon unless it’s necessary. Make it easy for us to see why you’re a great fit!
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 the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at CAPU Search
✨Know Your Regulations
Make sure you brush up on the latest FDA regulations and guidelines, especially around AI-enabled medical devices. Being able to discuss specific regulatory pathways like 510(k) submissions will show that you’re not just familiar with the rules but can apply them practically.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you’ve successfully navigated regulatory challenges. Highlight any hands-on experience you have with technical files or direct interactions with regulators, as this will demonstrate your capability and confidence in the role.
✨Engage with the Team
Since this role involves collaboration with engineering and clinical teams, be ready to discuss how you’ve worked cross-functionally in the past. Show enthusiasm for working in a team environment and how you can contribute to product development beyond just compliance.
✨Stay Current on AI Trends
Given the focus on AI in this position, it’s crucial to stay updated on the latest trends and regulations surrounding AI in healthcare. Bring up any relevant articles or insights during your interview to demonstrate your genuine interest and proactive approach to learning.