This range is provided by Medibeam. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Medibeam

Role

Regulatory Affairs Consultant – SaMD & AI Driven Devices

Remote (UK based) | Software, AI, and Digital Health Focus | Permanent

Whether it’s mapping a regulatory strategy for an AI based clinical tool, drafting FDA ready documentation, stress testing a technical file before CE marking, or simple planning a launch, the types of projects you could work on are endless with this consultancy.

You’ll join a well known company that’s supporting some of the most exciting software and AI based MedTech products in the UK and EU. Even though the position is remote, the business cultivate a culture of collaboration, so you will never be alone.

What Your Week Might Look Like

• Coaching a founder through the early regulatory roadmap for their clinical decision support tool
• Reviewing technical documentation and dossiers before it goes to a Notified Body
• Advising on post market surveillance plans for a newly launched app based diagnostic
• Shape strategy for new SaMD technologies

Key Skillset

• Strong grasp of the software and AI development lifecycle, you understand the moving parts and how they map to compliance requirements.
• Hands-on experience in digital health, ideally with connected devices or wearables.
• Proven ability to take products from development through to submission (UKCA, CE, FDA)
• Solid working knowledge of IEC 62304 (software lifecycle)

As demand for their digital health expertise accelerates, this role will shape how the consultancy evolves in the SaMD and AI space.

You won’t just contribute but actually define the direction.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting

Industries

• Medical Equipment Manufacturing

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