Overview
Maxim Beilin serves as VP Operations and CISO at AEYE Health[1][3]. Beilin is a healthcare operations executive with experience leading software as a medical device and medical device programs from concept through regulatory clearance and market deployment[2]. Beilin has directed cross-functional execution across quality, regulatory affairs, product, research and development, and cybersecurity functions, with expertise in FDA, MDR, ISO 13485, ISO 27001, CE, SOC 2, and HIPAA compliance[2]. Prior to joining AEYE Health in January 2025, Beilin held the position of QA/RA Manager at Viz.ai from January 2022 to January 2025[4]. Beilin's earlier roles included QA/RA Manager at CartiHeal from 2020 to 2022[5], QA Lead at Medasense Biometrics Ltd. from 2017 to 2020[6], and QA Team Leader at BD from 2014 to 2017[7]. Beilin holds a degree in Digital Health Regulation from Tel Aviv University as of 2024[10] and a Regulatory Affairs Specialist certification from Afeka Tel Aviv Academic College of Engineering in 2021[11].
Profile introduction
Healthcare Operations executive with a proven track record of leading global SaMD and medical device programs from concept to regulatory clearance and market deployment. Experienced in driving cross-functional execution across QARA, Product, R&D, and Cybersecurity, ensuring compliance with FDA, MDR, ISO 13485, ISO 27001, CE, SOC 2, HIPAA etc. Specializing in scaling operations, optimizing regulatory pathways and enabling fast, agile submissions in AI-driven healthcare environments. Transforming innovative concepts into safe, compliant and impactful (medical) solutions.
Career history
- VP Operations and CISOJan 2025 to presentAEYE Health
- QA/RA ManagerJan 2022 to Jan 2025Viz.ai
- QA/RA Manager2020 to 2022CartiHeal
- QA Lead2017 to 2020Medasense Biometrics Ltd.
- QA Team Leader2014 to 2017BD (CME)
- QA Manager2010 to 2014IWI Int'l
- Office of the Prime Minister of Israel2005 to 2010Office of the Prime Minister of Israel
Education
Digital Health Regulation2024Tel Aviv University
- Regulatory Affairs Specialist (RAS) at Afeka Tel Aviv Academic College of Engineering2021
- Manager of Quality/ Organizational Excellence Certification (CMQ/OE) at ALD College2017
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