|
Ms. Kiviharju joined Nanogen in August 2007 as the Vice President, Clinical, Regulatory Affairs and Quality Assurance, with over 14 years of regulatory, quality and clinical experience in the In Vitro diagnostics medical device (IVD) and biologics industries. Prior to joining Nanogen, Ms. Kiviharju was Senior Director, Regulatory Affairs at Gen-Probe Incorporated, responsible for obtaining product approvals internationally and in the US for products regulated by both CBER and CDRH at FDA. Previously, she held management positions in quality assurance and regulatory affairs at Blood Systems, Inc. in Scottsdale, AZ, the nation’s second largest blood collection organization. Ms. Kiviharju obtained her Bachelor of Laboratory Technology/Microbiology degree from the University of Regina, Canada. | 