Regulatory Advisor for SaMD & AI-enabled Medical Devices

About the role

Regi is seeking a Regulatory Advisor to work directly with the founder on shaping regulatory strategy, product direction, and commercial development for software as a medical device (SaMD) and AI‑enabled medical technologies. This senior advisory position offers immediate operational and strategic impact.

Key responsibilities

• Pressure‑test Regi’s positioning against new and emerging guidance across supported jurisdictions.
• Influence decisions on expanding regulatory coverage and prioritising jurisdictional growth.
• Leverage your network to make warm introductions that support Regi’s commercial pipeline.
• Provide senior commercial judgement on pricing and market positioning.
• Connect Regi with current regulator and notified‑body thinking on AI/ML topics.
• Act as a senior sounding board on regulatory science and ecosystem strategy.

Required profile

• Senior regulatory leadership experience in SaMD/AI‑enabled medical devices across at least two jurisdictions (UKCA, EU MDR, FDA).
• Proven track record of owning or leading high‑risk device submissions.
• Active professional network in UK, EU, and US regulatory science.
• Deep understanding of AI/ML‑specific regulatory considerations such as change control, post‑market performance monitoring, bias evaluation, and transparency.
• Prior advisory or non‑executive experience with venture‑backed companies.

Required skills

What we offer

• Equity‑based advisory engagement with a standard vesting schedule.