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Arthur P. Location
New York, NY, US
Arthur P. Work
VP, Global Regulatory Affairs and Quality Assurance @ (January 2024 - Present)
Global Head, Design Quality Engineering, Class II SaMD, AI and ML, Diabetes Management @ (January 2021 - January 2024)
Senior Manager, Integrated Quality, AI and ML, RW Patient Data and Evidence and Oncology @ (January 2020 - January 2021)
Head of R and D Engineering, New Product Development, Capital Equipment and Medical Imaging @ (January 2019 - January 2020)
Head of Regulatory Affairs and Quality Assurance, Class II SaMD and Clinical Surveillance @ (January 2017 - January 2019)
Senior R and D Program Manager, New Product Development, Surgical Powered Stapling @ (January 2013 - January 2017)
R and D Engineering Manager, New Product Development, Capital Equipment and Ultrasound @ (January 2010 - January 2013)
Senior R and D Product Development Engineer, Oral Healthcare and Biomaterials @ (January 2007 - January 2010)
Project Engineer, Capital Equipment and Radiation Oncology @ (January 2006 - January 2007)
Arthur P. Education
University of Hartford
Master of Business Administration - MBA (Finance)
2011-2013
Syracuse University
Bachelor of Science - BS (Biomedical & Electrical Engineering (Bioinstrumentation))
2002-2006
Arthur P. Skills
21 CFR 820
Agile Methodologies
Analytical Skills
Auditing
Business Correspondence
Business Development
Change Management
Compliance Management
Confluence
Continuous Improvement
Corrective and Preventive Action (CAPA)
Design Control
EU MDD & MDR
Engineering
Engineering Management
FDA GMP
Global Regulatory Compliance
Good Manufacturing Practice (GMP)
IEC 60601
IEC 62304
IEC 62366
ISO 14971
ISO Standards
Internal Audits
Interpersonal Skills
Jira
Lean Manufacturing
Management
Manufacturing
Manufacturing Operations
Medical Device R&D
Medical Devices
Mobile Applications
Operations Management
Problem Solving
Product Development
Product Management
Program Management
Project Management
Project Planning
QADirector
Quality Assurance
Quality Management
Quality System
Regulatory Affairs
Regulatory Approvals
Regulatory Compliance
Research and Development (R&D)
Risk Management
Scrum
Software Development Life Cycle (SDLC)
Software Quality Assurance
Strategic Planning
Strategic Thinking
Strategy
Team Leadership
Testing
Arthur P. Summary
Arthur P., based in New York, NY, US, is currently a VP, Global Regulatory Affairs and Quality Assurance at Ivy Biomedical Systems. Arthur P. brings experience from previous roles at Welldoc, Flatiron Health, KUBTEC Medical Imaging and Capsule, a Philips company. Arthur P. holds a 2011 - 2013 Master of Business Administration - MBA in Finance @ University of Hartford. With a robust skill set that includes 21 CFR 820, Agile Methodologies, Analytical Skills, Auditing, Business Correspondence and more. Arthur P. has 1 emails and 3 mobile phone numbers on RocketReach.
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