Karim Djamshidi
Role: Associate
Site: CDL-Berlin
Stream: Health
Karim is a MedTech executive with 15+ years of experience in Regulatory Affairs, Digital Health, corporate strategy, and transformation — including over ten years at KARL STORZ in global leadership roles.
Three threads run through his career:
Regulatory affairs as foundation. He built and led the global Regulatory organization, guiding the MDD-to-MDR transition across 50+ product lines, serving as PRRC under Art. 15 EU MDR, and shaping approval strategies for both new developments and the existing portfolio. He has been the point of contact for authorities and Notified Bodies worldwide, including the FDA and NMPA, and led the EU MDR working group at industry association SPECTARIS.
Transformation as craft. As VP Corporate Strategy & Transformation Office, he steered company-wide programs — from the group-wide rollout of a Balanced Scorecard to the integration of a Digital Surgery acquisition (robotics) to global organizational development.
Technology as origin. With a background in software engineering (M.Sc., MBA), he began his career in medical imaging and consulting for software-based medical devices. He understands digital products not just from a regulatory standpoint, but technically as well.
What drives him: making innovation possible in regulated markets — with clear structures, resilient decisions, and teams who know what they’re working toward.