Samantha Graham

Supported the preparation and submission of regulatory documents for ongoing clinical evaluations in alignment with FDA regulations and standards. Conducted regulatory research to inform product development and ensure strategic alignment with global compliance requirements. Assisted in the development of regulatory strategies through cross-functional collaboration with Clinical, R&D, and Quality teams. Led process improvements to streamline regulatory workflows.
Additional Projects:
Cancer Research Advocacy Focus Team (CRAFT) Involvement
Organized and facilitated internal awareness seminars and events. Served on a planning committee for an internal innovation challenge, including event coordination and stakeholder engagement. Led a team that developed a solution addressing product delivery inefficiencies; presented findings and recommendations to a cross-functional audience.
R&D Laboratory Research & Data Analysis
Contributed to the design of experimental protocols to evaluate material binding and exchange properties in simulated biological environments. Supported optimization of experimental method to ensure test readiness. Developed and implemented detailed labeling systems to enable rigorous traceability and uphold future data integrity.
R&D Test Method Development & Technical Characterization
Developed and validated a method for retrieving pre-formed particulate samples from fluid-based systems. Supported flow testing and obstruction analysis to assess delivery system feasibility and guide iterative design enhancements.