Michael Willingham Email and Phone Number
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30+ years of experience in the healthcare technology industry, with roles in Regulatory Affairs, Quality Assurance, Information Security, Research, Product Development, Human Resources and International Business. 20+ years as a senior executive. Specific experience in healthcare IT, medical device design and manufacturing, embedded and stand-alone software, management system certifications, total quality management, and worldwide regulatory affairs. An effective leader able to organize, motivate, and develop people. Experienced in industry standards development and regulatory agency policy development. Technical expertise in safety, security, reliability and quality engineering principles. Chairperson for international (IEC) and national (AAMI) medical device standards committees on electromagnetic compatibility, external defibrillators and pacemakers. I have been an active member of several industry groups including AAMI, AdvaMed, ASQ, HIMSS, IEC and NEMA/MITA. I have led several organizations to achieve certifications to international management standards: ISO 13485 Quality Systems (based on ISO 9001), ISO 27001 Information Security Management Systems, ISO 14001 Environmental Management Systems and BS 18001 Occupational Health & Safety.
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Affiliate Associate ProfessorSchool Of Pharmacy University Of WashingtonSeattle, Wa, Us
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Affiliate Associate ProfessorSchool Of Pharmacy University Of Washington Apr 2023 - PresentSeattle, Washington, UsBiomedical and Regulatory Affairs MS and Certificate programsThe University of Washington’s Master of Science in Biomedical Regulatory Affairs trains professionals to effectively manage the process of bringing new medical products to market. In this two-year program, abbreviated as BRAMS, candidates develop expertise in the regulations governing medical product development and learn how to lead every step of the regulatory process.https://sop.washington.edu/department-of-pharmacy/graduate-education-training-programs/ms-in-biomedical-regulatory-affairs-brams/ -
Director, Regulatory Affairs, Google Health At GoogleGoogle Jun 2020 - Nov 2024Mountain View, Ca, UsAt Google we’re committed to improving the lives of as many people as possible. One of the most important areas in which we’re striving to do that is health. We’re studying the use of artificial intelligence (AI) and machine learning to assist in diagnosing cancer, predicting patient outcomes, preventing blindness, and much more. We’re exploring ways to improve patient care, including tools that are already being used by clinicians. And we’re partnering with doctors, nurses, and other healthcare professionals to help improve the care patients receive. Check us out at https://health.google/ -
Vice President, Regulatory Affairs & Quality Assurance98Point6 Inc. Oct 2016 - Jun 2020Seattle, Washington, Us98point6 is pioneering a new approach to primary care by pairing deep technology with the expertise of board-certified physicians. Our innovative service offers consistent access to comprehensive care in sickness and in health, and includes diagnosis, treatment, prescriptions and labs as well as consultation for any health-related question. We provide accessible care with uncompromising quality—all at a massively lower cost than anything else on the market today. -
Vp, Quality Assurance And Regulatory AffairsCaradigm Jun 2012 - Sep 2016Caradigm is a population health company dedicated to helping organizations improve care, reduce costs and manage risk. Offices in US, Europe and China. As the Vice President for Quality Assurance and Regulatory Affairs, I was responsible for the company's management systems for quality, information security and privacy. I was also responsible for assuring that our software products met worldwide regulations and industry standards.
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Sr. Director, Quality & RegulatoryPhilips Healthcare 2006 - Jun 2012Amsterdam, Noord-Holland, NlPhilips Ultrasound is a division of Philips Healthcare with multiple medical device manufacturing sites located in the U.S., Canada and China. Headquartered in Bothell, WA. -
Vp, International Business OperationsMedtronic Physio-Control 2004 - 2006
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Vp, Quality & RegulatoryMedtronic Physio-Control 1995 - 2004
Michael Willingham Skills
Michael Willingham Education Details
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University Of MississippiBsee -
University Of WashingtonEngineering
Frequently Asked Questions about Michael Willingham
What company does Michael Willingham work for?
Michael Willingham works for School Of Pharmacy University Of Washington
What is Michael Willingham's role at the current company?
Michael Willingham's current role is Affiliate Associate Professor.
What is Michael Willingham's email address?
Michael Willingham's email address is mi****@****hoo.com
What is Michael Willingham's direct phone number?
Michael Willingham's direct phone number is +120648*****
What schools did Michael Willingham attend?
Michael Willingham attended University Of Mississippi, University Of Washington.
What skills is Michael Willingham known for?
Michael Willingham has skills like Medical Devices, Iso 13485, Quality Assurance, Fda, Regulatory Affairs, Quality System, Cross Functional Team Leadership, Design Control, Capa, Leadership, 21 Cfr Part 11, Iso.
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