Somi Ekwealor
Regulatory Affairs Lead @Intuitive
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WORK HISTORY
Regulatory Affairs Lead @Intuitive
EDUCATION
Purdue University
Bachelors of Science in Pharmaceutical Sciences (BSPS), Medicinal Chemistry and Molecular Pharmacology (MCMP)
University of Southern California
Master of Science (MS), Regulatory Science
ABOUT SOMI EKWEALOR
Influential, performance-driven leader using my 15+ years of regulatory experience in pharmaceuticals, medical devices, and combination products to strategize global commercialization of groundbreaking products.Currently specializing in the robotic medical device and Software as a Medical Device industries supporting global strategies and submissions for state of the art devices often requiring clinical studies. Successfully led regulatory product development activities and gained market clearance for numerous 510(k)s under multiple divisions of US FDA as well as internationally across EMEA, APAC, LATAM and North America.Leading major initiatives to drive regulatory excellence and redefine the role of regulatory affairs as an interactive, intellectual, strategic business partner and company resource to achieve significant public health goals. Creatively utilizing artificial intelligence (AI) to augment role.
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