Regulatory Advisor (S/AIaMD)

About Regi

Regulatory compliance for S/AIaMD is complex. The rules are dense, the frameworks differ by jurisdiction, and the cost of getting it wrong (delayed launches, failed audits, wasted development cycles) falls hardest on the teams least equipped to absorb it.

Regi was built to change that.

We're a regulatory intelligence platform purpose-built for SaMD and AI-enabled medical technologies. We help product teams, founders, and compliance leads understand exactly what's required to bring a device to market (across FDA, EU MDR, and UKCA frameworks) without needing a full regulatory affairs function in-house.

We work with teams from early-stage product development through to multi-device post-market compliance across multiple jurisdictions.

We're built around the core belief that regulatory clarity shouldn't be a competitive advantage available only to large, well-resourced organisations.

The role

We are appointing a Regulatory Advisor to work directly with the founder on regulatory strategy, product direction, and commercial development. This is a working advisory position. The right person will have substantive operational and strategic input from day one.

The remit includes, but is not limited to:

• Pressure-testing Regi's positioning on new and emerging guidance across supported jurisdictions
• Shaping decisions on where the platform deepens regulatory coverage next, including jurisdictional expansion priorities
• Making warm introductions across your network to support Regi's commercial pipeline
• Bringing senior commercial judgement to pricing and positioning
• Connecting Regi to current regulator and notified body thinking on AI/ML topics
• Acting as a senior sounding board on regulatory science and ecosystem strategy

What makes you a great fit

• Senior regulatory leadership in S/AIaMD with substantive experience across at least two of our supported jurisdictions (UKCA, EU MDR, FDA)
• A track record of owning or leading high risk device submissions
• An active network across UK/EU/US regulatory science
• Fluency in AI/ML-specific regulatory considerations: change control, PCCPs, transparency, bias evaluation, post-market performance monitoring
• Prior advisory or non-executive experience with venture-backed companies

Compensation and structure

Equity-based advisory engagement on a standard vesting schedule.