Eric Chen serves as the Director of Regulatory Affairs within Abbott’s Global Regulatory Services, where he plays a pivotal role in shaping the regulatory landscape for the company’s innovative medical device portfolio. With over 20 years of experience in the medical device industry, Eric has...
Eric Chen serves as the Director of Regulatory Affairs within Abbott’s Global Regulatory Services, where he plays a pivotal role in shaping the regulatory landscape for the company’s innovative medical device portfolio. With over 20 years of experience in the medical device industry, Eric has cultivated a deep expertise in cardiovascular devices, particularly in the realm of mechanical circulatory support systems, as well as neuromodulation technologies like deep brain stimulation. His extensive background also encompasses the development of orphan products and pediatric devices, making him a versatile leader in navigating complex regulatory pathways.
In his current role, Eric is instrumental in managing regulatory strategies that align with Abbott’s commitment to advancing healthcare solutions. He leads key projects that involve the submission and approval processes for Premarket Approvals (PMAs) and Humanitarian Use Devices (HUDs), ensuring compliance with FDA regulations while advocating for innovative therapies that address rare diseases. His unique combination of clinical and regulatory experience allows him to bridge the gap between scientific innovation and regulatory requirements, fostering collaboration across multidisciplinary teams.
Eric’s leadership extends beyond regulatory submissions; he actively engages in policy development and advocacy efforts that shape the future of medical device regulations. His proficiency in biomaterials and life sciences, coupled with his strategic vision, positions him as a respected thought leader in the industry. As Abbott continues to push the boundaries of medical technology, Eric Chen remains at the forefront, driving initiatives that not only meet regulatory standards but also enhance patient outcomes globally.
