Megan Brandt joined Sunshine Heart in August of 2016 as Vice President of Regulatory Affairs and Quality Assurance. Prior to joining Sunshine Heart, Brandt served as Vice President of Quality and Regulatory Affairs at Cardiovascular Systems, Inc. (CSI), a company focused on developing and commercializing innovative solutions for treating peripheral and coronary vascular disease. At CSI, she successfully facilitated numerous domestic and international clinical study submissions and secured multiple regulatory approvals including CE mark, multiple 510(k) clearances, and original PMA approval for their peripheral and coronary orbital atherectomy systems.
She currently serves as Co-Chair for Medical Alley’s Regulatory Advisory Board and is actively involved in multiple FDA working groups including Harmonization by Doing and MDEpiNet’s RAPID programs. In 2014, she was nominated by Minnesota Business Magazine as an Emerging Healthcare Leader. Brandt has held several leadership positions at multiple medical device and pharmaceutical companies including Medafor, Inc., and PDL BioPharma.
Brandt earned her B.S. in Biochemistry and Microbiology from Minnesota State University-Mankato.