Rajesh Misra

Principal, Life Sciences Quality and Regulatory Services Leader at Kpmg Llp @KPMG

Boston, MA, US

I’m a Principal in KPMG LLP’s Operations practice and lead our Quality and Regulatory services for the life sciences industry. I’m an experienced life sciences professional specializing in Quality and Regulatory functions of pharmaceuticals and medical devices. I advise clients from strategy through execution in current good manufacturing practices (“cGMPs”) and quality systems, regulatory pathways, commercialization, and post-market surveillance. I assist companies in implementing effective quality management systems for product quality and regulatory compliance, including the implementation of complaint handling and medical device reporting solutions.In commercialization, I provide strategic guidance on regulatory pathways and market approval requirements for pharmaceuticals and medical devices, leveraging my knowledge of US and EU regulatory frameworks.With expertise in digital health solutions, I help organizations utilize technology advancements, including artificial intelligence and machine learning, to improve patient care and optimize processes while adhering to the regulatory pathways for digital health solutions.For the past 5+ years, we’ve been at the forefront of the EU MDR transition programs for several of our medical device clients. I’ve helped companies through every phase of their transition from EU MDD to EU MDR.I assisted several pharmaceutical manufacturers and wholesale distributors in designing, developing, and implementing product serialization solutions to comply with the Drug Supply Chain Security Act (DSCSA).Additionally, I assist clients in quality issue remediation and addressing inspectional observations, guiding organizations in planning, and executing effective remediation strategies for compliance issues.KPMG LLP, the audit, tax and advisory firm, is the U.S. member firm of KPMG International Cooperative (\"KPMG International\"). Thoughts expressed here are my own.

Gorakhpur University, Gorakhpur India

B.S., Physics, Chemistry, Maths

MMM University of Technology

Master’s Degree, Computer Applications