Irene Díaz Rodríguez

Irene Díaz Rodríguez is a highly experienced regulatory professional with a focus on medical devices and combination products. Currently serving as Manager, Regulatory Device and Combination Products Lead at Biogen, Irene is responsible for defining regulatory strategy plans, conducting global assessments for software applications, and ensuring compliance with EU MDR regulations. Previous roles include QMS & Regulatory Manager and Specialist at Roche, where Irene managed documentation and implemented quality management systems for software as medical devices, and Technician Inmunochemical Control at Grifols, specializing in analytical methods. Irene holds an MBA in Pharmaceutical and Biotechnological Industry and advanced degrees in Biotechnology and Microbiology from Universitat Autònoma de Barcelona.