Feride Cengelli

I studied chemical engineering at EPFL and completed a PhD in Life Sciences at the University of Lausanne, where my research focused on using nanoparticles as drug-delivery systems for cancer therapy. Following that, I built a career in regulatory affairs within international medical devices and in vitro diagnostics companies, particularly dealing with cardiovascular interventions products at Biosensors and at Biotronik, and with diagnostic instruments at Roche Diagnostics. I guided internal and external stakeholders throughout the entire product lifecycle—from early development to market launch—ensuring compliance with regulatory requirements and anticipating emerging regulations for products across all risk classes. Among other responsibilities, I focused on coordinating, preparing, reviewing, and submitting regulatory dossiers to obtain market authorizations across Europe (i.e. CE Mark), North and Latin America (e.g. 510(k), HUD, HDE), the Middle East, Africa, and Asia-Pacific countries. In response to new European regulations (MDR/IVDR), I conducted gap analyses and implemented the necessary changes to organizational processes.
I later worked as a market surveillance inspector at Swissmedic, enforcing legal and regulatory actions for medical devices among Swiss economic operators.
Today, with 14 years of experience in regulatory compliance, I aim to bridge economic market demands with legal and policy frameworks. In this context, new technologies and innovations act as catalysts for the entire healthcare system, fueling my passion for advancing the healthcare sector.