Jill Kaeder oversees the Quality and Regulatory Affairs departments in her role as Vice President of Regulatory Affairs and Quality. Her career in quality and/or regulated environments spans over 25 years, with device specific expertise in software as a medical device (SaaMD), imaging systems, general purpose reagents (GPRs) and device accessories.
Her strengths are in the creation and implementation of systems, evaluating a system’s impact on other areas, organizing and assessing data for submissions, and interpreting the needs of Quality Assurance/Regulatory Affairs to a software developer, another department or an implementation team. She has extensive experience translating compliance and regulatory standards in line with business and tech advancements, assessing and balancing risk associated with applied compliance practices, and interfacing with local and international regulatory bodies such as FDA, European competent authorities and notified bodies.
