Regulatory Affairs Officer

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’ll 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 maybe some flexibility for the right person.

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