Pane Kamchev

Background

About Pane Kamchev

With a background in molecular and evolutionary biology, I transitioned from academic research into regulatory affairs of medical and in vitro diagnostic devices. Over the past two years, I’ve developed a strong interest in Post-Market Surveillance and Vigilance, knowledge in EU MDR, IVDR, Swiss MedDO, IvDO, ISO 13485, and hands-on experience in guiding medical device manufacturers though onboarding processes for Authorised Representative and Regulatory Importer services for the Swiss, EU and UK market. I bring a client-focused, detail-oriented approach to regulatory compliance, supporting documentation review, customer onboarding, and cross-functional project coordination. My scientific training allows me to think critically, communicate clearly, and approach complex problems with precision and planning. Colleagues describe me as a proactive and resourceful team player who brings a positive mindset and humor during challenges. I value authenticity and take pride in persistence, diligence, and compassion.