25 YEARS IN PRODUCT DEVELOPMENT (R&D), QUALITY ASSURANCE, REGULATORY AND MANUFACTURING (MEDICAL DEVICES, COMBINATION PRODUCTS AND PHARMA) Results driven leader and contributor at any level capable of making critical decisions and creating deliverables with positive outcomes for multi-million dollar initiatives. With a successful track record of product clearance, company certification/registration, commercialization, remediation, and organizational development, able to formulate complex programs with specific goals, while building up, supporting and leading the team to achieve them. Breaks down functional and cultural barriers to achieve professional alignment and organizational effectiveness, while earning the respect and trust from all levels of the company. Willing, able and flexible to conduct any task within the development lifecycle. #MedicalDevices #FDA #CombinationProducts #CMC #Pharmaceuticals #Regulatory #QualityAssurance