Sara Pezzini, MS
Regulatory specialist providing FDA regulatory support for medical device submissions and clinical research initiatives involving novel healthcare solutions.
Sara supports regulatory readiness by monitoring research documentation, overseeing clinical trial operations, and coordinating compliance activities to ensure programs remain consistent, traceable, and prepared for review. Drawing on a background in molecular biology, she brings a thorough scientific foundation to regulatory work involving innovative healthcare products. Her responsibilities include preparing and maintaining regulatory documentation and supporting clinical trial activities in alignment with applicable regulatory requirements.
Area of Focus/Expertise:
- Regulatory compliance and FDA submission support
- Clinical trial documentation, monitoring logistics, and IRB/DSMB filings
- Investigational Device Exemption (IDE) study coordination
- Quality systems alignment and GxP compliance
- Clinical study evidence management and documentation traceability
- Biotechnology regulatory pathways and commercial strategy
Selected Experience & Impact
Sara supports advancements in regulatory and clinical initiatives by coordinating essential documentation, quality processes, and clinical trial activities. She helps ensure that development programs remain organized and aligned with applicable regulatory requirements. Her work includes contributing to IDE activities, supporting the preparation and organization of regulatory submissions, and establishing and maintaining systems for effective management of regulatory records.
Background & Credentials
Sara is a graduate student at Johns Hopkins University pursuing a Masters of Science in Biotechnology where she focuses her studies on regulatory affairs and product commercialization. She holds a background in life sciences, having earned a Bachelor of Science degree in Biology.
Sara emphasizes her background in life sciences into her work by integrating a strong understanding of scientific processes, data interpretation, documentation practices, and adherence to established procedures. She combines technical knowledge and expertise in regulatory requirements, effectively supporting documentation precision, submission activities, quality processes, and cross-functional operational coordination.