Amsterdam, North Holland, Netherlands
I lead regulatory engineering and global market access for medical devices and digital health software across the EU, UK, and US. I design regulatory frameworks and leverage AI-assisted tools and automation to simplify documentation, maintain traceability, and accelerate market entry. I have achieved MDR CE marking and ISO 13485 certification, led successful FDA submissions, and built and scaled high-performing regulatory teams. I have also provided regulatory consulting across medical devices, IVDs, and cosmetics. My work spans EU MDR, FDA regulatory pathways, SaMD, clinical development, and post-market surveillance, translating complex regulatory requirements into practical strategies that enable cross-functional teams to deliver compliant, market-ready products. Passionate about healthcare innovation, I focus on transforming regulatory complexity into efficient pathways that bring life-saving and AI-enabled technologies to market while balancing compliance, quality, and business impact.