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Supira Medical

Global Regulatory Affairs Lead, Cardio Medical Devices

los gatos, CA

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Job description

Supira Medical in Los Gatos, CA, seeks a senior Regulatory Affairs professional to lead US, EU, and Japan submissions for a class III medical device. Hybrid role with close collaboration to our Regulatory team and consultants.

You will plan strategy, write major submissions (IDE, PMA, EU Dossiers, Shonin), manage timelines, and maintain labeling compliance across markets while guiding internal teams.

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Worksite address

los gatos, CA, 95032, US

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