Regulatory Affairs Specialist

2 weeks ago

London, Greater London, United Kingdom Indo Search Full time £85,000 per year

Regulatory Consultant – Permanent - Remote - SaMD/AI

  • SaMD and AI Focus
  • Fully Remote UK (or Ireland) - must be residing in the UK (or Ireland)
  • Circa £85,000 per annum, depending on experience, with flexibility for a SaMD expert.

If you have hands-on regulatory experience with software-based medical devices and you enjoy working directly with engineering teams, this role is likely to suit you.

The consultancy supports AI researchers, early spinouts and scaling digital health companies across the UK, Ireland and the EU. They need someone confident in determining software and AI product classification, shaping early regulatory strategy and guiding clients through documentation and submissions.

You will work remotely from either the UK or Ireland and will be the regulatory lead for a variety of clients developing SaMD and AI-driven products.

You should be comfortable with IEC 62304/SaMD aligned documentation, software lifecycle requirements, technical file preparation and regulatory expectations for AI models entering regulated pathways.

If you are looking to deepen your technical expertise in SaMD and build exposure to the latest digital health technologies, you will thrive here.

What You Will Do

  • Guide clients through the classification of software and AI based products for MDR, IVDR and FDA.
  • Shape regulatory strategies for early-stage development and market entry.
  • Prepare and review technical documentation and artefacts aligned to 62304 and wider SaMD expectations.
  • Support design reviews, risk management and clinical evaluation planning.
  • Advise founders, product teams and engineering groups on regulatory best practices throughout the development lifecycle.

What You Will Bring

  • Proven regulatory affairs experience within software, SaMD or digital health.
  • A clear understanding of MDR, IVDR and FDA 510k requirements.
  • Strong familiarity with 62304, software lifecycle processes and technical documentation.
  • Confidence working directly with software, ML and engineering teams.
  • An interest in deepening your knowledge of AI and software-based regulation.
  • An organised, practical communication style that helps clients move forward.

Who You Will Be Joining

A long-established regulatory consultancy with a strong reputation in the SaMD and digital health sector.

Their clients range from academic researchers spinning out for the first time to scaling startups building complex AI-driven devices.

The team is small, collaborative and highly knowledgeable, and you will have plenty of support as you take ownership of your own projects.

The structure gives you significant variety, responsibility and the chance to grow your expertise in one of the most innovative areas of MedTech.

Please apply today or contact for more information

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