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Shweta Daga

Director of Regulatory Affairs at Elixir Medical Corp.

Shweta Daga is an expert in regulatory affairs within the medical devices industry, with a focus on cardiovascular and software-based devices.

She has a strong background in leading regulatory strategies and discussions with the U.S. FDA, as well as planning and technical writing for submissions in the U.S., Europe, and various other regions.

Shweta has extensive experience in dealing with different country audits and maintaining global product approvals.

With a detailed understanding of regulatory compliance and various standards, she specializes in regulatory submissions for different markets, regulatory strategic operations, and clinical regulatory affairs.

Shweta Daga's educational background includes a Bachelor's degree from Rajashtan University of Health Sciences, a Master's degree from Rajiv Gandhi Prodyogiki Vishwavidyalaya, and a certificate from UCSC Silicon Valley Extension.

She has held key roles in reputable organizations such as Director of Regulatory Affairs at Elixir Medical Corporation, Director of Regulatory Affairs at ReCor Medical, Manager (Sr.) of Regulatory Affairs at Cordis, and various senior regulatory affairs positions at other esteemed companies.

Throughout her career, Shweta has demonstrated expertise in regulatory submissions like IDE, PMA, 510(k), and EU MDR Dossier, as well as overseeing international submissions in countries like Canada and Japan.

Her skills also extend to regulatory operations, project management, and leadership in regulatory and quality functions.

With a solid foundation in standards such as ISO 13485, 9001, 62304, 60601, and 14971, Shweta Daga is proficient in ensuring compliance with regulatory requirements and quality systems.

In summary, Shweta Daga is a seasoned regulatory affairs professional with a broad skill set and significant experience in navigating the complexities of the medical devices regulatory landscape.

Shweta Daga
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Location

San Francisco Bay Area