Arthur P.
Global Strategic Leader in Med Device & HealthTech | Driving Efficient & Compliant Class II & III Med Device Commercialization | SaMD, AI/ML, Imaging Systems & Surgical Instruments | SDLC Agile/Scrum | OpEx Six Sigma
- Role
- Director, Global Regulatory Affairs and Quality Assurance, Precision Medicine at Ivy Biomedical Systems
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Arthur P.
Proven global strategic business technical leader with a proven track record of driving…
Experience
Director, Global Regulatory Affairs and Quality Assurance, Precision Medicine
Jan 2024 — Present · New York, NY, US
o Lead the global regulatory strategic roadmap for Class I & II electrocardiography medical device portfolios and their accessories. US FDA, Health Canada, EU MDR, PMDA, NMPA, etc. o QA/RA lead on several new product commercialization initiatives with key strategic partners.o Supplier Quality oversight and driving QMS development with continuous process improvements.o Management of CAPAs, Design Control, and SDLC initiatives.o Deployment of Risk Management programs, Usability/Human Factors Engineering activities, and Cybersecurity Risk Analyses.o Conducting Reliability Testing and ensuring compliance with EU MDR technical file requirements, including CEP, CER, PMS Plans/Reports, PSUR, and PMCF.o Facilitating Internal and External Audits, IEC 60601-1, 60•••12 compliance (-2-27-2-33), and EMC testing standards.
Education
Syracuse University
Bachelor of Science - BS
University of Hartford
Master of Business Administration - MBA
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