Background
Somi Ekwealor is a regulatory affairs professional with extensive experience in robotically-assisted surgical devices and minimally invasive surgical devices. Mr. Ekwealor specializes in development and execution of global regulatory strategies that enable commercialization of innovative technologies. Mr. Ekwealor has authored and reviewed various U.S. regulatory submissions for combination products and medical devices including 510(k)s, INDs, IDEs, Breakthrough Device Designation requests, and Humanitarian Use Device (HUD) designation requests. Mr. Ekwealor has focused experience in various applications of robotically-assisted surgical devices and equipment including cardiac, pulmonary, and general surgery. Mr. Ekwealor has developed successful IND and IDE study applications while leveraging real-world data and pre-clinical study data when possible. Mr. Ekwealor is experienced in leading engagements with FDA and other global regulatory authorities, fostering trusted relationships that facilitate efficient review of marketing applications.
Education
Somi Ekwealor received a Master of Science in Regulatory Science from University of Southern California and a Bachelor of Science in Pharmaceutical Sciences in Medicinal Chemistry and Molecular Pharmacology from Purdue University. In addition, he received Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS).
Experience
Somi Ekwealor has over 14 years of experience building and executing regulatory strategies for medical devices, while focusing on robotically-assisted surgical devices since early 2019. Mr. Ekwealor has authored several successful U.S. FDA submissions as well as international submissions, including landmark approval for the first robotically-assisted platform for endobronchial surgery in China.
Overview
As Director of Robotics and EMC Regulatory Affairs, Somi Ekwealor collaborates with key stakeholders to support the development of robust regulatory strategies and submissions for novel robotic medical devices. Mr. Ekwealor manages the design, review, and implementation of pre-clinical testing and interacts directly with regulatory agencies throughout the various pre-submission and final review processes.