Yann Cailler, founder and director of Next Regulatory, is a seasoned regulatory affairs and quality assurance consultant with over a decade of experience in the medical, diagnostics, and combination product industry. With a comprehensive understanding of global regulatory frameworks and an unwavering commitment to holistic and pragmatic compliance approach, Yann has helped companies of all sizes—ranging from startups to multinational corporations—navigate complex regulatory landscapes and achieve market success.

Yann’s qualifications and expertise make him a key partner for medtech companies:

• Regulatory Strategy: Proven ability to design and execute tailored regulatory strategies that align with business goals and ensure timely product approvals in international markets.
  Global Compliance: Deep expertise in managing submissions for U.S. FDA 510(k) filings, European MDR and IVDR compliance, and global market registrations, including Japan and other regions.
• Process Optimization: Skilled in implementing efficient tools and workflows, such as regulatory information management systems (RIMS), to streamline processes and reduce time-to-market.
• Emerging Fields Expertise: Specialized knowledge in cybersecurity, artificial intelligence, and digital health regulations, making him well-equipped to guide companies operating in cutting-edge areas of medtech innovation.

Yann’s background is engineering complemented with a Master’s Degree in Health Economics and Pharmacoeconomics. In addition to be the author of multiple patents, including innovations in electrophysiological mapping electrode systems, Yann’s academic background is complemented by multiple certifications such as MR Safety, cybersecurity, and reprocessing.

Throughout his career, Yann has:

• Managed and scaled high-performing regulatory teams, ensuring efficient operations and fostering a culture of excellence.
• Played a pivotal role in securing regulatory approvals for complex products by developing innovative regulatory and quality strategies.
• Collaborated with regulatory bodies and cross-functional teams to address challenges, ensuring smooth and successful interactions.

Yann’s approach as a consultant is built on collaboration, adaptability, and a results-driven mindset. He works closely with clients to deliver actionable guidance, helping them turn regulatory challenges into opportunities for growth.