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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

VoxelCloud

Open Positions (1)

Management

Vice President – Regulatory Affairs