Spencer Walker

About Spencer Walker

Spencer is a Regulatory Affairs and Quality Executive and Consultant/Advisor in the Medical Device industry. Spencer has over 20 years in the medical industry Including 13 years in Medical Device Regulatory/ Quality Compliance. Spencer currently works with the University of Utah’s Center for Medical Innovation, teaching and consulting for new university based medical device start-ups, and is the founder and managing partner at Peak Regulatory Consulting working with industry based companies. Spencer holds an international Master’s degree (MSc) in Translational Medicine from Cranfield University in the UK and did his internship in Cambridge with a real-time blood monitoring company. He also earned his Bachelor\'s Degree in Biology with an emphasis in human diseases from Utah Valley University.Just prior to creating his own regulatory consulting firm, Spencer worked with Edwards Lifesciences in their Minimally Invasive Heart Valve Surgery device development group for over 5 years, leading both FDA and International submissions. Specialties- Extensive operative and academic regulatory background of the FDA 510(k) Premarket Notification process and filing requirements, and the European (EU) filing requirements (CE Marking Process), and submission requirements for other international regulatory bodies. Product experience includes: Cardiovascular Catheters and Cannulae, Cardiovascular and ENT Reusable Surgical Instruments, Light Therapy (LED and Laser) devices for Acne and Urology, Blood/Glucose Monitoring devices, Laparoscopic/ Endoscopic devices, Cervical Cancer Thermal Coagulation devices, Vein Anastomosis devices, Asthma devices, Pediatric Oxygen Administration devices, Infertility Gamete Processing devices, Muscle Strength Insufficiency Testing devices, In-Vitro Diagnostic devices, Neonatal ventilation systems, Urinary Assist devices, Electrical Body Impedance devices, Physical Therapy devices, Software Based Psychoanalysis devices, Dental devices, including electrical devices requiring IEC 60601 and Software Validations, and many more.

Experience

1. Director of Regulatory Affairs

   Center For Medical Innovation

   Dec 2015 — Present

   Within the University is the Center for Medical Innovations (CMI). Here we help student and physician inventors learn the process of getting their medical inventions to the market. I am the Director of Regulatory Affairs and have set up processes and systems to assist inventors to start their own businesses and get them on the right regulatory and quality footing before they go and brave the real world market. I also run the mixed MBA/ Industry executive education\'s BioVentures (Life science MBA) program in conjunction with the Eccles School of Business, and the Medical School at the university.

Education

• Utah Valley University

  Bachelors in Science, Biology w/ emphasis in Human Diseases

  1997 — 2005

• Cranfield University

  MSc Translational Medicine, Drug and Medical Device development

  2006 — 2008

• Payson High School

  HS Diploma, Science

  1994 — 1997