Stephen Amato, PhD, MBA, RAC (US/EU) is currently a Program Director, FDA Regulatory Affairs and Market Access, at Northeastern University. He is also a Managing Director of East Coast Operations at Cardinal Health Regulatory Sciences, a group that partners with global pharmaceutical, biotechnology and medical device companies. He has vast experience in the global medical device, IVD and biotech spaces; with an extensive track record in the regulation, reimbursement and commercialization of life science technologies in oncology, orthopedics, biomaterials, women's health, & infectious diseases.