

Detail-oriented life sciences professional with hands-on experience in GMP-regulated, sterile cytostatic manufacturing, currently pursuing a CAS in Regulatory Affairs, Life Sciences (Medical Devices). Strong background in compliance-driven processes, documentation control, and validated systems (Apoteca, BD CATO, SAP). Actively transitioning into Regulatory Affairs with a solid understanding of EU MDR, Swiss MDR requirements, risk-based decision-making, and medical device lifecycle compliance.