Nathan Blazei Kymanoz

Nathan Blazei is the Head of Quality & Regulatory Affairs at Kymanox, a life science consulting firm serving clients on their mission of bringing modern medicine to patients in need. Nathan leverages his 20 years of experience in the life sciences to provide optimized solutions to clients with respect to innovation, product quality, and patient safety. Today he specializes in quality management system development and optimization, outsourced quality oversight, regulatory pathway assessments, regulatory body inspection readiness, marketing authorization submissions, auditing, gap assessments, and risk management programs. He has presented at industry events on various topics relevant to the life sciences, and he continues to offer training internally and externally to share best practices, lessons learned, and new approaches to old problems. As a member of PDA for many years, Nathan has enjoyed the information exchange with fellow life science professionals and wants to build a more collaborative environment in the Southeast Region so that the industry as a whole can benefit from each other's knowledge and experiences. Previously, Nathan held technical roles at Liquidia, Novartis Vaccines & Diagnostics, Grifols/Talecris Biotherapeutics, ev3, and Boston Scientific. Nathan has a Bachelor of Science degree in Chemical Engineering from the University of Notre Dame and a Master of Engineering degree in Bioengineering from the University of California, San Diego. He is a Certified Quality Auditor (CQA) through the American Society for Quality and holds a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society.