About

Sandra Schaerer-Lickova is Regulatory Affairs Manager at Ypsomed, where she supports strategic regulatory projects for pen injectors and drug-device combination products. She started her regulatory career in the pharmaceutical sector, preparing common technical documents and managing medicinal product submissions, before expanding into medical technology. Her expertise spans EU MDR CE marking, Article 117 assessments and US FDA CFR regulations for medical devices and combination products, alongside registrations in global markets, including the US, China, Korea, Brazil and Russia.

With a background in chemistry and bioprocess engineering, she now focuses on lifecycle management, technical documentation and guiding cross-functional teams to ensure regulatory compliance and successful market access.