Pranitha Dcunha

I am passionate about advancing safe and effective medical technologies through strong regulatory strategy, compliance, and post-market surveillance. Currently at Abbott, I manage complaint evaluations and regulatory reporting for Class III cardiovascular medical devices, helping ensure patient safety and regulatory compliance across global markets.

My experience spans regulatory affairs, clinical publishing, and medical device compliance. During my regulatory affairs co-op at Abiomed, I contributed to 510(k) and PMA submissions and supported audits, inspections, and Health Canada reporting. I also developed regulatory strategy and validation frameworks for a wearable device during a regulatory strategy internship, aligning with FDA, Health Canada, and ISO standards.

Previously at Labcorp Drug Development, I prepared and quality-checked clinical regulatory documents in eCTD format while supporting CAPA investigations to strengthen submission quality. I am particularly interested in the intersection of regulatory science, risk management, and innovation, ensuring that emerging medical technologies reach patients safely and efficiently.

My goal is to continue contributing to the development and lifecycle management of innovative medical devices that improve patient outcomes worldwide.