Ravi A.

WORK HISTORY

EDUCATION

SKILLS

ABOUT RAVI A.

As Director of Packaging in the pharmaceutical industry, I have successfully built and scaled packaging organizations to develop complex devices for combination products. I established robust design control procedures and work instructions to integrate product development with GMP compliance, ensuring the highest standards of safety, quality, and regulatory adherence. I have created and led high-performing packaging teams across the U.S. and internationally, collaborating closely with regulators (FDA) to secure product approvals and accelerate time-to-market. In addition, I developed comprehensive training programs to enhance the capabilities of new engineers, equipping them with the expertise required to navigate the demands of this highly regulated industry. My expertise spans regulatory compliance, cross-functional leadership, risk management, process optimization, and continuous improvement, with a particular focus on design control, verification, and validation. I have successfully launched a wide array of products, including neurovascular devices (catheters, stents, embolic devices), auto-injectors, transdermal patches, ophthalmic systems, and pre-filled syringes. Driven by a mission to develop safe and effective medical devices, I am committed to improving patient outcomes and enhancing the quality of life for people worldwide.