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
The skillset that will thrive:
* 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.