Director, Global Regulatory Affairs, Precision Medicine @ (November 2019 - June 2023)
Senior Manager Regulatory Affairs @ (June 2018 - October 2019)
Senior Consultant, In Vitro Diagnostic Devices @ (January 2015 - May 2018)
Master Reviewer @ (February 2010 - December 2014)
Reviewer @ (July 2003 - January 2010)
Kate Simon Education
University of Virginia
Doctor of Philosophy (Ph.D.)
1995-2000
University of New Hampshire, Durham, NH 1990-1994
Kate Simon Skills
510(k)s
Cancer Screening
Clinical Protocols
Clinical Trials
Companion Diagnostics (CDx)
Consulting
FDA
IVDR
In Vitro Diagnostics
Infectious Diseases
Medical Devices
Microbiology
Molecular Biology
Oncology
PMAs
Pharmaceutical Sciences
Pre-clinical Studies
Precision Medicine
Regulatory Affairs
Regulatory Submissions
Virology
Women's Health
Personalized Medicine
Pre Clinical Studies
510ks
Kate Simon Summary
Kate Simon, based in Belle Haven, VA, US, is currently a Senior Director, Global Regulatory Strategy IVD at Bayer. Kate Simon brings experience from previous roles at GSK, QIAGEN, Biologics Consulting Group and FDA/CDRH/OIR. Kate Simon holds a 1995 - 2000 Doctor of Philosophy (Ph.D.) @ University of Virginia. With a robust skill set that includes 510(k)s, Cancer Screening, Clinical Protocols, Clinical Trials, Companion Diagnostics (CDx) and more. Kate Simon has 3 emails and 2 mobile phone numbers on RocketReach.
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