Senior Manager, Regulatory Affairs

Yesterday

🏢 In-office - Bay Area

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Logo of HeartFlow, Inc

HeartFlow, Inc

HeartFlow is a medical technology company transforming the way cardiovascular disease is diagnosed and treated$1. .$1

201 - 500

Description

• Oversee activities pertaining to successful pre-market development • Ensure regulatory compliance • Manage worldwide submissions for new products and product changes • Collaborate with key internal partners • Monitor applicable regulatory requirements • Provide regulatory support for currently marketed products • Establish/maintain good relationships with regulatory authorities

Requirements

• Bachelor’s Degree • 8+ years regulatory medical device experience, including 5+ years management experience • 5+ years working with software as a medical device, extreme familiarity with current regulatory thinking around software and AI

Benefits

• cash bonus • stock options

Apply Now
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