Data and results driven leader in the Medical Device Regulatory Affairs space providing servant leadership and top tier Regulatory strategy guidance while maintaining the highest standards of compliance. 12 years of experience (including seven years of managerial experience) in device types including: capital equipment, electromechanical equipment, standalone software and device firmware, vascular and non-vascular catheters, urological equipment, lasers, embolization, respiratory interface devices, and reproductive health products. Direct writing experience in 510(k), PMA, 513(g), EU technical file, and Canadian license; submission support experience in China, Japan, LTAM, and EMEA.