Avital Levertov, MA

אביטל לברטוב

Senior Regulatory Affairs Expert for Medical Devices in the U.S. Market, Project Manager, and Lecturer at GSAP. Avital brings over 14 years of proven experience in the medical device industry, specializing in U.S. medical device regulations, with hands-on experience in a wide range of FDA interactions, including:

• Premarket applications submitted via eCOPY and eSTAR
• Pre-submissions
• FDA inspections and responses to Form 483 and Untitled Letters
• Handling Reports of Correction and Removals with the FDA

In her role as Regulatory Affairs Manager at an international medical device company, Avital led complex regulatory submissions and successfully managed all stages of the regulatory process — from regulatory involvement in various product development phases, through FDA submissions, and into the post-marketing stage (including QSR requirements per 21 CFR Part 820, Registration and Listing per 21 CFR Part 807, and Reporting, Correction, and Removals per 21 CFR Parts 803 & 806). Over the years, Avital has gained both academic and practical experience, participating in numerous courses and seminars related to U.S. and EU regulations. She has developed expertise in building regulatory strategies tailored to the U.S. market, with a deep understanding of regulatory requirements across a wide range of medical products. Her track record includes writing, preparing, and successfully submitting medical devices to the U.S. market; planning, preparing, and managing Pre-submission meetings; successfully managing regulatory inspections; overseeing regulatory reporting and product recalls; and professionally handling regulatory correspondence, including Form 483 and Untitled Letters. Avital shares her extensive knowledge in a practical, hands-on manner, offering unique insights from her experience with U.S. regulatory requirements for medical devices.