Former Vice President, Regulatory Affairs at Abbott Rapid Diagnostics, Joins NDA Partners as Expert Consultant

ROCHELLE, Va.: ROCHELLE, Va., Aug. 10, 2021 /PRNewswire-PRWeb/ — NDA Partners President Earle Martin announced today that Leanne Kiviharju, a senior regulatory affairs executive with more than 20 years of experience leading regulatory operations in the in vitro diagnostic industry, has joined the firm as an Expert Consultant. Ms. Kiviharju’s experience focuses on FDA-regulated molecular and rapid diagnostic products, as well as global regulatory registrations in Europe, Canada, Asia, and Australia. Ms. Kiviharju has held senior leadership roles as Vice President, Regulatory Affairs at Abbott Rapid Diagnostics (formerly Alere, Inc.) and Vice President, Clinical, Regulatory Affairs, and Quality Assurance at Nanogen. She also held senior director roles in regulatory affairs at Illumina and Gen-Probe, where she was responsible for achieving the first FDA authorized next generation sequencing platform and first nucleic acid blood screening assay for HIV-1 and HCV, respectively. Prior to these roles, she was Regulatory Affairs Manager and…
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