Donald A. Middlebrook

About Donald A. Middlebrook

Donald A. Middlebrook, formally Sr Vice President of Clinical, Regulatory and Quality at Nevro Corporation. Previous e patience: Don served as a a Consultant to Abbot working with Global Regulatory and Clinical Affairs. Prior to the Thoratec acquisition, Don was responsible for overseeing all regulatory, clinical affairs and corporate quality activities for the company’s products worldwide. Before joining Thoratec, Don held the position of Senior Director, Global Regulatory Affairs and Quality Assurance for Chiron Vision, a division of Chiron Corporation involved in the manufacturing of ophthalmic surgical devices. In addition, Don spent fifteen years with Baxter International in a number of leadership positions including Vice President of Regulatory Affairs and Quality Assurance for the Cardiovascular Group (now known as Edwards Lifesciences). Don holds a bachelor’s degree in Biology from California State University, Fullerton. Throughout his career, he has been actively involved in a number of professional organizations including AdvaMed and Regulatory Affairs Professional Society (RAPS). In 2005, Don was elected to the RAPS Board of Directors, and in 2008 he was nominated as a RAPS Fellow (FRAPS). In 2011, Don was appointed President Elect of RAPS. From 20••••14, Don served as Chairman of the RAPS Board of Directors. In 2015, Don was appointed Chairman of the RAPS Nomination Committee, a position he currently holds today. Alongside his experience in the medical device industry, Don has over six years of voluntary service as a Board Director, as Vice-Chairman and as Chairman of the Saddleback Memorial Medical Foundation (SMMF) Board of Directors. Don also served as Chairman of the SMMF Business Advisory Council and Chairman of the SMMF Executive Committee. In total, Don has 15 years of experience as a member of the Board of Directors for RAPS, BioView and Saddleback Memorial Medical Foundation.

Experience

1. Consultant, Regulatory, Clinical and Quality

   Three Rivers Consulting, Llc

   May 2024 — Present · US

Education

• University of La Verne

  Business

  1984 — 1986

• Orange Coast College

  AA, Biology

  1972 — 1974

• California State University, Fullerton

  BA, Biologoy

  1974 — 1976

Skills

• Design Control
• Regulatory Submissions
• Quality Assurance
• Medical Devices
• Clinical Research
• Capa
• Quality Auditing
• Biotechnology
• Sop
• Fda
• Iso 13485
• Manufacturing
• Quality System
• V&V
• Clinical Trials
• Validation
• Gmp
• Regulatory Affairs