CovarsaDx

Tim Krauskopf

Sr. Regulatory Strategist

With 30+ years of experience, Tim has exhibited deep expertise in all facets of the healthcare industry, most notably in quality assurance, clinical trials, and regulatory affairs.

Over his illustrious career, he has successfully held several senior leadership roles. In his latest appointment as Vice President — Quality at Siemens Healthcare Diagnostics, he was responsible for quality, regulatory, and clinical affairs supporting the point of care diagnostics business. Tim has played an instrumental role in multiple product launches through clinical trials, registration efforts, and post-market quality processes. His most notable achievements have been bringing the 3rd party COVID-19 antigen self test to the worldwide markets and enabling more than €2B in sales.

Previously, Tim served as Vice President — Regulatory Affairs at Siemens and spearheaded global regulatory functions supporting the Laboratory Diagnostics business.

Tim earned his B.S. in Biology from the University of the State of New York, Excelsior College in Albany, NY. He was also an active member of the Alpha Lambda Delta National Honor Society and the Regulatory Affairs Professional Society.

Apart from his work with mainstream healthcare giants, his experience also extends to BLK Medical, a startup where Tim led all regulatory, quality, and clinical functions to develop a novel device for treating myocardial infarction.
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