An innovative, passionate and certified Regulatory Affairs and Quality Assurance Professional with 16 years’ experience in medical device and combination product new product development research, engineering, and commercialization. Nine years of quality assurance, quality control and regulatory affairs educational and hands on experience. Strong leadership, interpersonal, and technical skills which will bring value to any organization striving to design and supply products that improve patient quality of life in the medical device, biotech and pharmaceutical industries.