Vice President – Regulatory Affairs

Job not on LinkedIn

🕒 March 20

🏄 California – Remote

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⏰ Full Time

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

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Logo of VoxelCloud

VoxelCloud

11 - 50 employees

🏭 Manufacturing

🤖 Artificial Intelligence

🏥 Healthcare

💰 Series B on 2019-12

Manufacturing • Artificial Intelligence • Healthcare

VoxelCloud is a Los Angeles-based leader worldwide in artificial intelligence (AI) analysis of medical images. Founded in 2016, VoxelCloud is a start-up company focused on medical artificial intelligence, providing automated medical image analytics and diagnostics services. The company's proprietary algorithms leverage deep learning techniques to deliver accurate and personalized medical image analysis for conditions such as lung cancer, retinal diseases, and coronary heart disease. VoxelCloud also operates a satellite R&D team in Phoenix.

📋 Description

• Guide team regarding all FDA-related matters before, during and after clinical trials • Manage and engage with FDA and outside counsel • Draft required company documentation • Define and execute regulatory strategy in support of company objectives • Plan and execute FDA and regulatory activities • Represent VoxelCloud to regulators during pre-submissions and submissions • Complete regulatory submissions and compliance assessments

🎯 Requirements

• 5+ years successful experience driving health software through FDA clearance process • Diagnostic AI software experience is strongly preferred • Good personal network of contacts in the health software RA field • In-depth knowledge of the U.S. healthcare system • Appropriate bachelor’s degree; advanced degree preferred

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development

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