Wendy Kivens

Wendy Kivens, Ph.D., RAC (US), is a seasoned regulatory affairs professional with extensive experience in the medical device and diagnostics sectors. Currently serving as Director of Regulatory Affairs at Sherlock Biosciences since June 2024, Wendy Kivens provides strategic regulatory guidance to support the commercial strategy and expedite the sale of OTC in vitro Diagnostic Medical Devices (IVDs). Previous roles include Director of Regulatory Affairs at binx health, where regulatory submissions were developed and prepared, and Director of Regulatory Affairs at Starkey Hearing, focusing on quality management systems and compliance. Wendy Kivens has also held significant positions at Wright Medical, ARKRAY, Inc., Smiths Medical, Beckman Coulter, Gentra Systems, and ViroMed Laboratories, showcasing a robust background in regulatory strategy, project management, and compliance within cross-functional teams. Wendy Kivens earned a Ph.D. in Biochemistry, Biophysics, and Molecular Biology from the University of Minnesota, along with an NRSA Postdoctoral Fellowship.