Grace Lee
About Grace Lee
Grace Lee serves as the Senior Director and Head of Global Regulatory Affairs at Predicine, bringing extensive experience from previous roles at Agilent Technologies, Foundation Medicine, and Medtronic. She holds a B.A. in Psychology and Pre-Medicine from The Johns Hopkins University and a degree in Biochemistry and Molecular Biology from the Johns Hopkins Bloomberg School of Public Health.
Current Role at Predicine
Grace Lee serves as the Sr. Director and Head of Global Regulatory Affairs at Predicine. She has held this position since 2022, contributing to the company's regulatory strategies and ensuring compliance with global standards. Her role involves overseeing regulatory submissions and interactions with health authorities, which are critical for the advancement of Predicine's diagnostic solutions.
Previous Experience in Regulatory Affairs
Before joining Predicine, Grace Lee worked at Foundation Medicine as Associate Director of Regulatory Affairs from 2020 to 2022. Prior to that, she spent three years at Agilent Technologies as Principal Regulatory Affairs Specialist for Companion Diagnostics, from 2017 to 2020. Her career also includes a role as Senior Regulatory Affairs Specialist at Medtronic for 11 months in 2016-2017 and five years as Senior Vice President of Regulatory Consulting at Pacific Bridge Medical from 2011 to 2016.
Educational Background
Grace Lee holds a Bachelor of Arts degree from The Johns Hopkins University, where she studied Psychology and Pre-Medicine/Pre-Medical Studies. Additionally, she studied Biochemistry and Molecular Biology at the Johns Hopkins Bloomberg School of Public Health, further enhancing her knowledge in the life sciences and regulatory affairs.
Expertise in Regulatory Affairs
With extensive experience in regulatory affairs, Grace Lee has developed expertise in navigating complex regulatory environments. Her roles have involved managing regulatory submissions, compliance, and strategic planning for various medical technologies and diagnostics. This background equips her to effectively lead regulatory initiatives at Predicine.