Gena D. Parker

Gena D. Parker serves as the Vice President of Regulatory Affairs, Quality Assurance, and Compliance at Semler Scientific since April 2020, overseeing regulatory, quality system, and compliance activities in accordance with FDA QSR's, ISO 13485, MDSAP, MDR, and HITRUST standards. Gena has a robust background in regulatory affairs, having held multiple leadership roles including Associate Vice President and Director of Regulatory Affairs, Quality Assurance, Quality Engineering & Compliance at Semler Scientific, where responsibilities included developing comprehensive regulatory strategies and engaging with various health authorities and stakeholders. Prior experience includes directing quality assurance and regulatory affairs at Phoenix DeVentures and managing document control at several medical device companies. With a career spanning over two decades, Gena D. Parker has extensive expertise in navigating complex regulatory environments and ensuring compliance across diverse product portfolios.