Angel Estrada
Vice President, Quality Assurance & Regulatory Affairs
Dr. Angel Estrada is a Senior-Executive U.S. FDA, Global Regulatory Affairs, Quality Assurance and Clinical Affairs Leader, and Teaching Faculty. An accomplished Senior QARA executive, Angel has worked in the US, EU & Global Quality and Regulatory Affairs for Medical Devices (Class I, II, III, manufacturing and design environments), & Pharmaceuticals/ Biotechnology (Oncology), comprising over 30 years of commercial industry experience. Dr. Estrada is a versatile Regulatory Affairs and Quality Assurance Expert demonstrating contributions in leading communications, strategies, and negotiations for regulatory submissions processes and their market approvals interacting with the US FDA, EU, Canada, Japan, Latin America (LATAM), Asia-Pacific (APAC) and ROW Global Regulatory Agencies, representing 120+ global markets globally, including leading Quality Assurance and Post-Market compliance. Angel has been a member of APACmed, MedTech EU and several ISO committees and ASQ committees. Angel came to BlueWind Medical from Neutron Therapeutics where he launched a BNCT Oncology treatment system. Previously, Angel spent over seven years at Hologic, Inc., a global medical device and diagnostics company where he served as VP of International Quality and Regulatory Affairs. During his tenure at Hologic, Inc., Angel was the regulatory and quality leader for all OUS business and suppliers, including worldwide distributors and legal entities. Prior, he was VP of Regulatory Affairs and Quality Assurance at Zimmer-Biomet, leading teams for the surgical, knee, hip, trauma and spine businesses. Other assignments included Head of Quality Systems and Regulatory Compliance roles at Kimberly-Clark Healthcare and Covidien as well as Head of Design Control/Reliability Engineering at Abbott Laboratories and Baxter Healthcare. Dr. Estrada is a graduate of Cadiz University Engineering School in Spain, as well as holding degrees from DePaul University in Business Administration, California State Masters in Quality Assurance and Indiana State Doctorate in Technology Management Quality Systems. Dr Estrada is a member of Graduate Regulatory Affairs (GRA) Program Faculty at the College of Professional Studies (CPS) at Northeastern University, Boston.