Ryan Hanson

Background

About Ryan Hanson

I am a Scientific Affairs Manager at ARKRAY USA, a global leader in the diabetes and in vitro diagnostics (IVD) markets. With 5 years of experience in the IVD industry, I have developed and demonstrated strong leadership, project management, and analytical skills that enable me to deliver multiple projects on time, navigate within complex FDA and ISO-regulated environments, and work cross-functionally with product development and regulatory affairs teams.My mission is to bring new and innovative medical devices to market by implementing effective regulatory strategies, executing well-planned clinical studies, and compiling complex technical and scientific evidence. My team is directly responsible for generating and compiling all clinical study and bench testing evidence required for Class II IVD Regulatory Submissions to FDA. Additionally, I have significant experience developing and implementing regulatory strategy through close collaboration with regulatory affairs teams and direct communication with FDA. I am proud to have contributed to multiple successful FDA clearances, and I hope to bring more quality medical devices to market in the future.