Cox was most recently VP of regulatory affairs for tissue and regenerative technologies at Integra LifeSciences (NSDQ:IART). He was responsible for regulatory approvals of new products and product extensions for the $480 million orthopedics and tissue technologies division. He also led efforts to develop FDA premarket approvals, 510(k)s, and investigational new drugs, as well as international registrations under the EU Medical Device Directive (MDD) and the new Medical Device Regulation (MDR).
Cox also integrated the product lines of the Ingtegra’s Derma Sciences and BioDlogics acquisitions, expanding his regulatory responsibilities to include advanced wound care and human tissue products.
Prior to Integra, Cox held regulatory positions at several medical device companies, including Terumo BCT, where he was responsible for Class II and Class III submissions in the Center for Devices and Radiologic Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) branches of the FDA related to pathogen reduction and blood-processing technologies. Earlier experiences include authoring numerous regulatory submissions for the U.S., EU, Canada, and Japan for Medtronic’s cardiac surgery division.
“I am pleased to have David join the Company as VP of Global Regulatory Affairs. His first priority is to expedite U.S. FDA regulatory approval of CytoSorb for ticagrelor removal, with the goal of targeting other antithrombotic drugs, as well as other critical care and cardiac surgery applications in the future,” said CytoSorbents president & CEO Vincent Capponi in a news release. “Meanwhile, David’s international regulatory experience is an added plus as we prepare for MDR in the coming years.”