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Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Lavanya Ramnath, MS

Senior Regulatory Affairs Specialist
Insulet Corporation

Lavanya Ramnath is a dedicated Regulatory Affairs professional with experience in US, EU and global regulatory strategy and submissions. She holds a Master’s degree in Medical Device and Diagnostic Engineering from the University of Southern California and a Bachelor’s degree in Biomedical Engineering from India.

Lavanya currently serves as a Regulatory Affairs professional on the US New Product Development team at Insulet Corporation for software- and algorithm-driven insulin pumps. She plays a key role in advancing feasibility and pivotal clinical trials through cross-functional collaboration for Insulet's future product portfolio. She authored 2 Original IDEs and multiple IDE supplements, serving as the primary point of contact with the FDA. Lavanya co-authored the 510(k) submission for the Type 2 indication of Omnipod 5 — the first insulin pump in the U.S. indicated for use in people with Type 2 diabetes. Additionally, Lavanya also supports sustaining activities for U.S. and EU markets ; along with process improvements across the business.

Prior to Insulet, Lavanya worked at Abbott Vascular, where she contributed to development and maintenance of implantable and non-implantable cardiovascular devices. She led and successfully achieved EU MDR approval for a New product - Class III balloon dilatation catheter. Her experience further includes supporting a 510(k) and modular PMA submission for Abbott's new product developments ; while she also led U.S post-market submissions & regulatory activities for Class II and Class III devices. She also drove global regulatory strategy and submissions across the product lifecycle for Asia-Pacific, Latin American and Emering Markets - including first in-country registrations, sustaining activities and retirement of legacy products.

Lavanya is passionate about ensuring regulatory excellence while supporting innovative medical technologies, through strong cross functional partnerships.
Lavanya is motivated by Abbott Vascular’s Mission Statement: "Built as if intended for my family."

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