Zoe Posner
Regulatory and quality specialist with expertise in Software as a Medical Device (SaMD) products, 510(k) premarket notifications, and document management.
Zoe Posner brings expertise in regulatory affairs and quality systems. She has specialized knowledge in Software as a Medical Device (SaMD) products. She has supported premarket submissions, document management, and quality control.
Areas of Focus / Expertise
- Premarket submissions including 510(k) preparation and strategy
- Quality systems development and implementation
- Risk Management development
- Technical writing and document review
- Cross-functional coordination across regulatory and development teams
Selected Experience & Impact
Zoe contributes to regulatory compliance by supporting premarket submissions, quality systems, and documentation processes that enable compliant and efficient product development. Her work includes leading 510(k) premarket notifications, assisting teams in preparing regulatory documentation, and developing and maintaining quality systems.
Background & Credentials
Zoe is currently pursuing a Master of Science in Regulatory Science at Johns Hopkins University, where she is developing advanced training in FDA Premarket Applications, cGMP compliance, Food and Drug Law, Clinical Development, Clinical Trial Design and Conduct, and AI and Software Regulation. She has a Honors Bachelor of Science in Pre-Veterinary Medicine from the University of Delaware and minored in Statistical Data Analytics and Animal Nutrition. With a background that combines life sciences and data analytics, Zoe brings a detail-oriented and analytical approach to regulatory work.