Nathan Blazei

Nathan Blazei has nearly two decades of life science industry experience and is skilled in various quality management system tools, regulatory strategy and filings, product and process development, process validation, continuous improvement methods, auditing and gap assessments, risk management, and regulatory inspection preparation, facilitation, and remediation. Nathan applies his engineering background to quality and regulatory compliance projects for clients to ensure that solutions are technically sound and compliant with current regulations.

Outside of Kymanox, Nathan worked for Liquidia, Novartis Vaccines & Diagnostics, Grifols and its predecessor Talecris Biotherapeutics, ev3 (now Covidien), and Boston Scientific. Nathan received 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. Nathan is a member of the Regulatory Affairs Professionals Society (RAPS). He is a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) and holds a Regulatory Affairs Certification (RAC-US) through RAPS. He has presented at domestic and international industry events on various topics relevant to the life sciences.