Pooja Hegde

Pooja Hegde is an experienced professional in Quality and Regulatory Affairs with a strong background in the healthcare and medical device industries. Currently serving as Associate Manager at Pramana since April 2025, Pooja previously held the position of Lead in the same department, where responsibilities included leading FDA testing activities, collaborating on regulatory compliance with subject matter experts, and optimizing the Quality Management System (QMS) in alignment with standards such as 21 CFR part 820 and ISO regulations. Pooja's career includes roles at Philips as a Complaint Handling Operations Investigator, where an average of 200 field complaints per month were managed, and at Merck Group as a Validation Engineer, engaging in risk management and maintaining compliance with Quality System Regulations. Educational qualifications include a Master’s degree in Biomedical/Medical Engineering from The University of Texas at Dallas and a Bachelor of Engineering from Thadomal Shahani Engineering College.