A Legacy of Regulatory “Firsts”

Jean-Noel’s career is defined by managing submissions for technologies that pioneered new regulatory categories:

• Pioneering AI at 23andMe: Directed the strategy and authored the software portions of the FDA submissions for early
  AI-driven data mining functions, resulting in the first-ever FDA authorization for direct-to-consumer genetic health risk reports.

• Deep-Tech Integration at Verily (Alphabet): Led the regulatory collaboration with Google for the design and EU submission of AI/ML digital imaging diagnostics. As a primary Intelligence Lead for the EU AI Act, he ensured that technical developments remained compliant with evolving standards.

• EU Legislative Engagement: During the drafting of the In Vitro Diagnostic Regulation (IVDR), Jean-Noel lobbied Members of the European Parliament (MEPs) and EU Commission advisors. This high-level engagement provided him with a "behind-the-curtain" understanding of how European policy-makers balance innovation with public safety.

Strategic Foresight: Learning from the MDR/IVDR Transition”

Jean-Noel offers a unique perspective gained from navigating the industry-wide transition from EU Directives to the Medical Device Regulation (MDR). Having managed this shift firsthand, he possesses deep insight into Notified Body expectations and the systemic risks of regulatory transitions.

He witnessed the "last-minute rush" that led to massive Notified Body backlogs, resulting in many companies being effectively barred from the EU market for years. Understanding that the EU Commission often releases final standards and guidance late in the process, Jean-Noel has developed a "Modular Readiness" strategy. He specializes in building robust compliance foundations while components are still missing, allowing companies to "plug in" final requirements efficiently as they are released. This proactive approach ensures his clients are at the front of the queue for Notified Body review, securing the "First-Mover Advantage" in the European market.

Professional Experience

With a track record spanning global leaders such as Roche and innovators like Mahana Therapeutics, where he secured the first-ever De Novo clearance for a standalone software digital CBT device, Jean-Noel bridges the gap between engineering and regulation.

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