IMDRF 2023

Nicole is an experienced global leader, passionate about ensuring worldwide patient access to life-altering medical products and building strong and efficient regulatory pathways that promote global public health.  

Nicole is a recognized expert in U.S. and international medical device/medtech/pharma and digital health regulatory law and policy.  With deep experience as a former U.S. Food and Drug Administration (FDA) official, and now as a senior executive in the private sector, she effectively builds consensus-driven bridges and public/private partnerships that lead to successful, measurable outcomes.  

From 2008-2016 Nicole served in various roles at FDA.  She joined FDA as Associate Chief Counsel in the Office of the General Counsel, Health and Human Services, at FDA headquarters in the Washington DC area.  Broadening her experience, she subsequently served as Acting Deputy Country Director and Assistant Country Director in FDA’s Beijing, China, office. 

In December 2022, Nicole joined Philips as Global Head Regulatory Science and Policy where she leads worldwide initiatives and provides strategic direction on medical device global regulatory science, policy, standards, and harmonization work. Prior to her role at Philips, she also served as Vice President, Global Regulatory Policy, Medtronic; Senior Director, Global Policy & Intelligence, Johnson & Johnson; and FDA/Life Sciences attorney, King & Spalding.

Nicole holds a Juris Doctorate from Vanderbilt University Law School and a Bachelor of Arts also from Vanderbilt in History and East Asian Studies.  She grew up in Southeast Asia and South America and enjoys continuing to work on her Chinese language skills.