Saakshi A.

Saakshi A. is a Regulatory Affairs leader with over 10 years of experience in medical devices, biotechnology, and digital health. Having held positions such as Senior Regulatory Affairs Program Lead at Johnson & Johnson and Manager of Regulatory Affairs at Limbix, Saakshi has successfully managed submissions for FDA 510(k), IND, and PMA while ensuring compliance with global health authorities. Saakshi has also earned a Master's in Business Administration from Saint Joseph's University and engaged in specialized training through the Duke University School of Medicine. Currently, Saakshi is focused on driving regulatory excellence and patient-focused solutions through collaboration and strategic planning.