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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

Colleen Watson
Senior Director Regulatory Affairs at Thermo Fisher Scientific

Profile

Colleen Watson, MS, is currently a Senior Director of Regulatory Affairs at Thermo Fisher Scientific working with in vitro diagnostics. Prior to this role she has also worked at Abbott Molecular, CareFusion/BD, and Vyaire Medical overseeing teams in the United States, Europe, Japan, and China. Through her work in infectious disease, oncology, therapeutic drug monitoring, biomarkers and respiratory devices she has been privileged to work with teams bringing new products to market. Colleen has also mobilized and guided companies on implementing new regulations, including UDI, EU MDR, and EU IVDR. She enjoys the challenge of building an effective team, bringing new products to the market, and seeing the direct benefit to patients.

Colleen received her B.S in Biochemistry from the University of Wisconsin-Madison. After graduating, she worked at the bench level doing drug chemistry and forensic toxicology, writing methods, and testifying in court. After earning a M.S. in Biotechnology, also from Madison, focused on integrating science, law, and business – Colleen fell in love with the Regulatory Affairs field. She is currently studying in the Doctoral Program in Regulatory Affairs at the University of Southern California focusing on design control for Software.

Agenda Sessions

  • Guidance Update: Significant Changes under Article 110(3) of the IVDR

    12:05pm
  • Multi-Stakeolder Panel: EU IVDR Expert Panels and PECP

    4:10pm