Lev Schwartz, MS
Regulatory affairs associate supporting medical device clients through the FDA 510(k) submission process. Lev combines graduate training in regulatory affairs with experience in client outreach, business development, and project management.
Lev Schwartz holds an MS in Biotechnology Management with a concentration in Regulatory Affairs, and his work spans both regulatory support and client-facing responsibilities. He contributes to the preparation of an FDA 510(k) submission, including regulatory documentation, submission strategy, and predicate device analysis, while also conducting client outreach and supporting business development. He organizes project activities and keeps work on schedule and on track. His background also includes regulatory research on FDA guidance for AI in drug development and maintaining data quality and tracking records for a health product inventory.
Areas of Focus / Expertise
- FDA 510(k) submission support
- Predicate device analysis
- Regulatory landscape and guidance research
- Regulatory documentation and technical writing
- Regulatory frameworks for AI/ML in pharmaceutical and medical device workflows
- Client outreach and business development
- Project management and scheduling
Selected Experience & Impact
Lev supports the preparation of an FDA 510(k) submission, contributing to regulatory documentation, submission strategy, and predicate device analysis. In parallel, he conducts client outreach, supports business development, and organizes the project to keep it on schedule and on track. Previously, he completed a regulatory landscape analysis of AI in the pharmaceutical space, identifying evolving FDA guidance and market authorization trends. The resulting report mapped the competitive regulatory environment and informed a regulatory niche strategy for an AI-driven scientific writing platform.
Background & Credentials
Lev holds an MS in Biotechnology Management with a concentration in Regulatory Affairs from Yeshiva University and a BS in Biological Sciences from Rutgers University. His training includes FDA submission pathways, including 510(k), IND, and NDA. Lev is interested in building his regulatory expertise in medical devices and supporting clients as they pursue market authorization.