Manager RA
Hologic Inc
Geethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with a deep belief in purpose-driven innovation. With over a eight of experience in global regulatory affairs and more than twenty years in healthcare, she brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology.
Starting her career as an occupational therapist, Priya’s focus has always been on impact- adding life to years, not just years to life. Today, she leads regulatory intelligence and digital transformation initiatives at a global medical device company, where she designs scalable systems to track emerging regulations, accelerate compliance, and enable access to life-changing technologies. Her work includes spearheading the development of an AI-powered Regulatory Information Management (RIM) platform that cut manual effort by 94 percent and brought real-time insights to global regulatory teams. She has led cross-functional strategies to secure approvals for high-risk and breakthrough devices, shaped early responses to policies like the EU AI Act and FDA’s evolving digital health guidance, and partnered across R&D, clinical, and quality functions to build compliance into innovation from day one.
Priya holds dual MBAs and is certified in RAC (Devices), PMP, ISO 13485 auditing, and medical device compliance. She thrives at the intersection of technology, policy, and strategy, and is known for her ability to bring clarity to complexity. Her mantra "make a choice, and make it happen" guides how she leads, builds, and mentors. Whether supporting teams through regulatory change or architecting AI-enabled solutions, she remains grounded in the mission that first drew her to healthcare: to serve, to simplify, and to make healthcare innovation more human.
Wednesday, October 8, 2025
1:00 PM - 2:00 PM EST