Arthur Pangaio
About
Arthur Pangaio is from New York City Metropolitan Area. Arthur is currently VP, Global Regulatory Affairs & Quality Assurance at Ivy Biomedical Systems, located in New York City Metropolitan Area. In Arthur's previous role as a Director, Global Regulatory Affairs at Ivy Biomedical Systems, Arthur worked in New York City Metropolitan Area until Jun 2026. Prior to joining Ivy Biomedical Systems, Arthur was a Global Head, Design Quality Engineering, Class II SaMD, AI/ML, Diabetes Management at Welldoc and held the position of Global Head, Design Quality Engineering, Class II SaMD, AI/ML, Diabetes Management at New York City Metropolitan Area. Prior to that, Arthur was a Senior Manager, Integrated Quality, AI/ML, RW Patient Data & Evidence / Oncology at Flatiron Health, based in New York, New York, United States from Jan 2020 to Jan 2021. Arthur started working as Head of R&D Engineering, New Product Development, Capital Equipment / Medical Imaging at KUBTEC Medical Imaging in Stratford, CT in Jan 2019. From Jan 2017 to Jan 2019, Arthur was Head of Regulatory Affairs & Quality Assurance, Class II SaMD / Clinical Surveillance at Capsule, a Philips company, based in Milford, Connecticut, United States. Prior to that, Arthur was a Senior R&D Program Manager, New Product Development, Surgical Powered Stapling at Medtronic, based in North Haven, Connecticut, United States from Jan 2013 to Jan 2017. Arthur started working as R&D Engineering Manager, New Product Development, Capital Equipment / Ultrasound at CIVCO Medical Solutions in Deep River, Connecticut, United States in Jan 2010.
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Arthur Pangaio's current jobs
·Direct report to CEO/President ·Executive leader responsible for global Quality, Regulatory Affairs, Risk Management, and Product Compliance for Class I and II medical device portfolios. ·Direct regulatory strategy and market access across FDA, EU MDR, Health Canada, PMDA, NMPA, and other international markets. ·Lead Quality Management System transformation initiatives supporting product innovation, operational excellence, and scalable business growth. ·Partner with executive leadership to commercialize next-generation medical technologies, integrating regulatory, quality, engineering, and clinical strategies. ·Drive inspection readiness and successful outcomes for FDA inspections, Notified Body audits, supplier audits, and customer assessments. ·Oversee Design Controls, Cybersecurity, Software Lifecycle, Human Factors, and Risk Management programs throughout the product lifecycle. ·Build and develop high-performing global QA/RA teams while fostering a culture of quality, accountability, and continuous improvement.
Arthur Pangaio's past jobs
o Direct report to the CEO, overseeing strategic initiatives. o Global department head, managing teams across the USA and India. o Management representative for ISO 13485, EU MDR, and MDSAP-certified QMS across multiple regions (USA, Canada, Australia, Japan). o Restructured, reorganized, hired, and onboarded a global QA team. o Led QA efforts for multiple successful Class II SaMD new product launches in partnership with global pharmaceutical and medical device companies. o Provided cross-functional expertise in areas including: Usability/Human Factors Engineering, Risk Management, Regulatory Affairs, Design Control, Agile/Scrum Methodologies, HITRUST Certification, Clinical Study Monitoring, EU MDR Compliance
o Flatiron acquired by Roche o QMS management for research unit in healthcare technology and cancer patient care. o Developed cross-functional quality processes using Lean/Six Sigma principles.
o Managed +10 cross-disciplined engineers including Mechanical, Software and Electrical. o Additional QA and RA responsibilities. o Direct report to CEO/President.
o Bernoulli Health acquired by Capsule / Philips. o Direct report to CEO/President. o Member of the site Executive Leadership Team (ELT) for QA and RA functions.
o Covidien acquired by Medtronic. o Senior R&D Program Manager (Powered Stapling): Managed global projects, driving R&D efficiency, budget, and mentoring. o Senior Design Quality Engineer: Led V&V activities, delivering $100K+ in savings (Lean Six Sigma Green Belt Project) and horizontally deployed best practices across global sites.
o PCI Medical acquired by CIVCO Medical. o Direct report to President/Owner. o R&D Engineering Manager with additional Quality Assurance and Regulatory Affairs responsibilities.
o NovaMin Technology acquired by GSK
o 100% domestic and international travel (USA, Canada and EU)