Navya Ghanta

About Navya Ghanta

I’m a Regulatory Affairs and Quality leader with over a decade of experience helping teams bring complex scientific ideas into regulated clinical use. Most of my work has focused on diagnostics, medical devices, precision medicine, and AI/ML enabled platforms, particularly in organizations moving from early development into regulated clinical and commercial readiness.I serve as a quality and regulatory partner to leadership and work closely with R&D, laboratory operations, bioinformatics, manufacturing, and operations teams to make sure quality and regulatory expectations are built in early, not added at the end. That includes building and shaping quality and regulatory frameworks from the ground up, along with validation plans, and operational processes in ways that reduce non-conformances, manage risk and support inspection readiness. I’ve led FDA facing activities, supported agency interactions, and driven ongoing readiness for CAP/CLIA labs and regulatory oversight in fast moving environments.Earlier in my career, I led U.S. and international regulatory activities for high-risk diagnostics and medical devices, partnering directly with the FDA, global regulatory authorities and key opinion leaders. I supported critical approvals and lifecycle compliance through complex submissions such as 510(k)s, BLAs, supplements, renewals, and annual reports and managed regulatory activities across regions such as EU, Canada, China, Australia, APAC, EMEA, and Latin America. Those experiences shaped how I approach my role today, using quality and regulatory frameworks to make clear decisions, align cross-functional and business priorities, and scale responsibly as both the science and organization evolve.I’m especially drawn to complex, novel technologies and teams navigating their transition from innovation to real world clinical impact. I value strong cross-functional partnerships, thoughtful risk taking, and building regulatory and quality foundations that support growth rather than slow it down.

Experience

1. Manager, Quality Assurance & Regulatory Affairs

   Prognomiq Inc

   Oct 2024 — Present

Education

• University of Southern California, School of Pharmacy

  Master of Science - MS (Regulatory Sciences)