Vice President – Regulatory Affairs

Job not on LinkedIn

🕒 March 20

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VoxelCloud

11 - 50 employees

💰 Series B on 2019-12

VoxelCloud is a start-up company focused on medical artificial intelligence. Founded in Los Angeles in 2016, we provide to clinical practices and practitioners automated medical image analytics and diagnostics services based on artificial intelligence and cloud computing technologies. Our proprietary algorithms offer accurate, accessible, and personalized medical image analysis through deep learning and related AI techniques. Our current products cover lung cancer, retinal diseases, and coronary heart disease. VoxelCloud also has 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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