Sharyn Orton, PhD

Dr. Sharyn Orton serves on the DZS Scientific Advisory Board as a clinical and regulatory executive adviser with specific expertise regarding medical devices and in vitro diagnostic (IVD) devices. She has served as the deputy director of the FDA’s Division of Blood Applications and has provided leadership and input to numerous industry sponsors. Dr. Orton has significant experience preparing and reviewing INDs, NDAs, PMAs, BLA, BLS and in vitro diagnostic submissions globally. A known expert in 21 CFR quality systems and FDA 483 examinations, Dr. Orton has submitted well over 30 510(k) submissions to the FDA. She has over 30 years of regulatory, clinical, and blood application and medical device application experience.

Dr. Orton has served as a senior leader within multiple consulting and industry organizations. In her role at the FDA, she worked on the CBER Bioterrorism Task Force and as OBRR counterterrorism coordinator. In these roles, she held responsibilities for process improvement including SOP development and revisions, as well as regulatory oversight of IDE, IND, master files, and BLA and BLS applications.

In addition to these professional accomplishments, Dr. Orton has authored dozens of presentations, abstracts and publications over the last 20 years, and she is the co-inventor of three U.S.-patented spectrophotometric methods in hematology.

Dr. Orton received her PhD in epidemiology and biostatistics from the University of South Florida in 2000. Prior to that, she earned an MS in public health with an emphasis on epidemiology and biostatistics from the University of South Florida.

Education and Memberships

  • PhD, Epidemiology and Biostatistics, University of South Florida, Tampa, FL (2000)
  • MS in Public Health; Epidemiology and Biostatistics, University of South Florida, Tampa, FL (1996)
  • BS, Pharmacy and Allied Health, Northeastern University, Boston, MA (1978)
  • Diploma in Medical Technology, New England Deaconess Hospital, Boston, MA (1978)
  • Virginia Commonwealth University, Medical Technology, Richmond, VA (1972-1974)