Scott has over 25 years of experience in the global medical device industry with a wealth of experience in global regulator and quality control systems. Most recently, Scott served as the Sr. VP of Regulatory & Quality at Vestagen Protective Technologies, Inc. Prior to that Scott was the Dir. of Regulatory & Quality Systems for WilMarc Medical and VP of Regulatory Affairs & Quality Assurance of Vascular Pathways, Inc. (VPI), leading to their FDA clearances of AccuCath BC and AccuCath EDC IV Catheters, as well as obtaining both organizations EN ISO 13845 and European Union (EU) Medical Device Directive (MDD) Annex II Certifications.
Scott has held multiple leadership positions in regulatory affairs and quality assurance, while throughout his career as both a consultant or within organizations, he has written or managed staff involved with obtaining market clearances, approvals, and/or registrations for hundreds of medical devices globally. Additionally, Scott worked with the Boards of Companies and Executive/Senior Leadership to develop and maintain strategies ensuring compliance with appropriate global regulations (e.g., FDA, Health Canada, EU MDD, Australia TGA, Japan MHLW-PMDA, etc.,). Scott is RAC (US) and ASQ (CQA & CHA) certified, and has served as the EU MDD Management Representative for many of the companies while leading their efforts in obtaining the necessary certifications to CE Mark their devices.
