Regulatory Affairs

  • 1063 Gayley Ave, Los Angeles, CA 90024, USA
  • Full-time

Company Description

Founded in 2016, VoxelCloud is a leader in AI analysis of medical images.  Backed by Sequoia and Tencent.  Our mission is to improve the quality and availability of healthcare with AI - improving outcomes for all.  http://www.voxelcloud.ai

Job Description

Self-motivated, highly experienced regulatory affairs professional to guide our team regarding all FDA-related matters before, during and after clinical trials.  The individual will also manage and engage on our behalf with FDA, outside counsel and other advisors regarding all VoxelCloud regulatory matters – including drafting all required company documentation.

Responsibilities:

  • Define and execute regulatory strategy in support of overall program goals and objectives
  • Build an AI-oriented Quality Management System (QMS) that meets the requirement of FDA regulations from major global markets (U.S. Euro etc.)
  • Provide day-to-day management of all regulatory aspects of our existing and future products
  • Advise and guide our product groups and company management on all regulatory matters impacting VoxelCloud – including R&D, clinical trial design, FDA Pre-Submission and post-trial approval process, etc.
  • Lead our timely engagement (including oral and written communications) with FDA, outside counsel and other advisors re: above.
  • Establish and manage best practices, processes and procedures supporting our Regulatory Affairs activities.

 

Qualifications

  • Graduate degree preferred
  • 5+ years of experience successfully managing FDA approval process and other regulatory matters for health software.
  • Very strong writing and documentation skills covering all QMS compliance and FDA application 
  • Deep knowledge in AI Radiology assisted diagnosis product features and their clinical & commercial value to providers and payers is a plus.
  • Based in or near Los Angeles:  this position is for our LA office.

 

 

Additional Information

All your information will be kept confidential according to EEO guidelines.