Liang Guo
Director of Regulatory Affairs @ Zimmer Biomet
About
I am the Head of Regulatory Affairs with over 20 years of experience in clinical support, engineering, validation, and global regulatory strategy for medical devices. I have a proven track record of leading regulatory submissions, including 510(k), PMA, and international approvals, while ensuring compliance with FDA and EU MDR requirements.Earlier in my career, I supported the clinical adoption, product development, and engineering collaborations for complex medical technologies. I excel at integrating regulatory strategy with R&D, quality, and senior leadership to drive product approval, lifecycle management, and global market access.I am committed to achieving safe, compliant, and scalable medical device innovation.
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United States
Capital Markets
Validation & Quality, Regulatory Affairs (FDA, EU MDR, 510(k), PMA)
Experience
Director of Regulatory Affairs
Zimmer Biomet
United States
Lead global regulatory strategy and submissions (510(k), PMA, international), ensure compliance with FDA and EU MDR, and align regulatory plans with R&D, Quality, and executive leadership to support product approvals and lifecycle management
Validation Engineer
Stryker
United States
Executed IQ/OQ/PQ validation for equipment, processes, and systems in compliance with FDA 21 CFR Part 820 and ISO 13485; led cross-functional validation efforts and risk assessments to support quality and regulatory readiness
Senior Application Engineer
Medtronic
United States
Led clinical application strategy for assigned products, managed key accounts, resolved escalations, and partnered with R&D to improve product performance and adoption
Clinical Applications Specialist
Medtronic
United States
Delivered product training and advanced clinical application support, optimized device workflows, and acted as liaison between clinical teams, sales, and engineering
Education
University of Massachusetts Lowell
Biomedical Engineering
Liang Guo's Contact Information
Phone
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