• Over thirty years of broad domestic and international experience in new product development, product launches and business acquisitions with major corporations andsmall start-up companies with specialized expertise in the medical device industry.• Demonstrated expertise in building business processes and organizations to achieve successful results.• First hand experience in interacting with regulatory agencies, including the Food & Drug Administration (FDA), European Union (EU) notified bodies and competent authorities, International Ministries of Health (e.g., TGA, DCGI, Health Canada), International Standards Organization (ISO), and Institutional Review Boards (IRBs)/Ethics Committees (ECs) • Degreed in engineering and applied statistics, certified in clinical research management with practical application of technical skills.Specialties: Medical Devices (US Class I, II and III) - Therapeutics, Active Implantables, Injectables, IVDs, Surgical Tools, Endoscopic Devices, Ultrasound, HIFU/HITU, Lasers, RFE, IRE/PEF, Neurostimulators, Magnetic Stimulation, LES Stimulation, Tinnitus Maskers, Catheters, Body Sensing & Monitors, Web-based applicationsRegulatory - US, Europe, Australia, New Zealand, Chile, Mexico, Columbia, Canada, IndiaClinical research trial design and managementQuality Systems development and management including FDA inspections, ISO certification and CE-marking