José Henrique Pereira Santos Tavares

I lead regulatory strategy, ANVISA submissions, and quality activities for medical devices and SaMD. At Bionexo Tasy, I manage technical dossiers, registration changes, labeling specifications, design controls, and compliance with key SaMD development standards.

Previously at Philips, I led Regulatory Affairs for an M&A/separation project, coordinated an ANVISA inspection with zero non-conformities, and supported registration and operating-license transfers. I also developed regulatory strategies supporting expansion across Brazil, LATAM, the EU, and the USA.

At BD, I managed ANVISA submissions and lifecycle activities across all medical-device risk classes, led UDI implementation for Brazil, and supported INMETRO and ANATEL certifications. I also implemented regulatory and document-management systems to strengthen traceability and audit readiness.

Across more than seven years in regulated healthcare environments, I combine regulatory monitoring, change-impact assessment, QMS support, CAPA, risk management, and cross-functional execution to support market access, business continuity, and compliance.