Rose PhanIndependent Consultant, Regulatory Affairs at MDRA Solutions Inc
Rose Phan is an Independent RA Consultant based in Vancouver, BC Canada. Rose graduated from Simon Fraser University holding a Bachelor Degree in Health Sciences. Through her consultancy (http://www.mdrasolutions.com/), she provides high-level expertise in the EU and international markets for medical devices.
Rose has over six (6) years of experience working on complex medical device submissions specializing in high-risk implantable medical devices, developed global regulatory strategies and conducted worldwide regulatory intelligence. Rose’s experience in International Regulatory Affairs is of considerable note. Rose has proven results with successful submissions in over 30+ regions including North America, Asia Pacific, Latin America, the Middle East, Africa, and Russia.
Currently, Rose is working on multiple EU MDR transition projects and is responsible for managing several MDD and MDR product portfolios, as well as updates to the CEP/CERs, preparing the STED submissions, SSCP, labeling and IFUs.