Vice President – Regulatory Affairs

Role Overview

• 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