Mr. Falcione joined ChemImage in December 2021 with extensive experience in FDA submissions and ISO/FDA quality system implementation. He is responsible for defining Quality and Regulatory strategies including milestone deliverables, budgets, and staffing required to accomplish performance business and technical objectives.
Prior to ChemImage, he was the Senior Vice President of Regulatory Affairs and Quality Assurance for ALung Technologies, focused on assessing company goals through business process improvements, gap analysis and remediation activities in areas of product development, quality systems, supply chain/supplier management, regulatory compliance (FDA, ISO, CE, etc.) and manufacturing. He has also severed as Vice President of Technologies for CHS Business Associates, Director of Strategic Quality at Emerson, as well as senior positions with Chiron Diagnostics and Ferranti Defense Systems.
Mr. Falcione earned his B.S. in Electronics Engineering from Pennsylvania State University and is EMBA from Baldwin-Wallace College. He is an adjunct faculty at Duquesne University supporting the Master’s Bioengineering program in the area of Regulatory, Quality and Product Development.