Jonathan LeeSpecialties: RegulatoryJonathan Lee is Principal Consultant and Managing Member of MedDev Consulting Solutions International. There, he provides strategic direction and tactical solutions for unique medical-device challenges – including integration of quality systems with compliance, product performance and elevated stakeholder expectations. He has also held consulting and senior-management positions in QA/RA, R&D, project management and product introduction disciplines- both in the United States and Australia. In addition, Mr. Lee has served as an instructor on quality systems at the University of Southern California School of Pharmacy Master’s Degree Program. A multiple patent holder, Mr. Lee possesses more than 25 years of broad-based medical device experience. His extensive quality system experience encompasses ISO, MDD & GMP standards and regulations. His prior roles include Vice-President of R&D at Cardiac Control Systems and Vice-President of Quality, Regulatory and Clinical affairs at Medtronic. Mr. Lee’s consulting roles have supported systems in implantable bio-stimulation telemetry, implantable heart subsystems, catheter defibrillation, surgical tools and vertebral stiffness measuring. His extensive experience also includes respiratory interfaces, cardiac catheter development, medical-device processes, quality system development/implementation and product approvals. Mr. Lee received his BE in Biomedical Electrical Engineering from the University of New South Wales, where he also completed post-graduate work in Computer Studies. Mr. Lee has participated in compliance symposia at Harvard University.
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