Fabien Roy

Partner at Arnold & Porter

Speaker

Fabien Roy is a recognized legal and regulatory leader and technical advisor for medical devices and in vitro diagnostic companies, with a strong reputation for developing effective regulatory strategies at EU and international level and for successfully resolving complex issues with competent authorities and third parties, including EU notified bodies.

With nearly two decades of experience advising life sciences companies, Fabien supports clients across a broad range of regulatory frameworks covering medical devices and IVDs, medicinal products (including ATMPs), combination products, and other regulated products such as food, feed, and cosmetics. He is particularly valued for his ability to translate complex regulatory requirements into pragmatic, business-oriented solutions and to lead complex, cross-border regulatory projects.

Fabien has a strong capability to lead pan-European and international regulatory projects and regularly advises on complex due diligence transactions involving companies operating across multiple jurisdictions. His work in this area includes assessing regulatory compliance, identifying risk exposure, and developing remediation strategies in the context of acquisitions, investments, and strategic partnerships.

Fabien is a trusted adviser on AI and digital health solutions, closely monitoring regulatory developments and guidance related to the AI Act, data protection and privacy legislation, and their interaction with medical devices and pharmaceutical regulatory frameworks. Known for anticipating regulatory hurdles, he helps clients remain compliant while advancing innovative technologies and commercial objectives.