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Shai Mayer has extensive experience in quality management and regulatory affairs within the medical device industry. As the Quality and Regulatory Manager at IR Med since July 2021, Shai is responsible for establishing an electronic Quality Management System (eQMS) in a software-driven medical device startup, focusing on ISO 13485 compliance. Prior experience includes serving as Project Manager and Business Excellence Program Lead at Nordson MEDICAL Advanced Components IL, along with roles as QA Manager at Nordson MEDICAL Israel, Global Quality Auditor at Shamir Optical Industry, and Quality Manager at SSOP. Shai holds degrees in Practical Mechanical Engineering, Quality Engineering, and Geology/Earth Sciences from various prestigious institutions, showcasing a strong educational foundation in both engineering and quality assurance.