Experience and Expertise
MaryLou is Vice President, Regulatory Affairs & Quality Assurance at Sirtex. In this role, she is responsible for driving the strategic direction for the global quality and regulatory affairs programs.
A licensed attorney and regulatory affairs professional, MaryLou has been involved in strategic business operations and regulatory planning in the medical device industry since 2006. She brings a successful track record of developing and executing Regulatory strategies to commercialize innovative medical devices.
Previously, MaryLou was Director, Regulatory Affairs at Mitralign, Inc., where she was responsible for obtaining regulatory approvals for a novel Class III cardiovascular implant device. Before that, she spent nine years at NxStage Medical, Inc., where she held roles of increasing responsibility within the Regulatory department, eventually becoming Director, Regulatory Affairs.
MaryLou holds a Juris Doctor from Suffolk University Law School, a Master of Business Administration from Rivier University and a Bachelor of Science in Business Administration from the University of Massachusetts at Lowell. She also completed the Regulatory Affairs Professional Society Executive Development Program at Northwestern University's Kellogg School of Management.
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