- 1063 Gayley Ave, Los Angeles, CA 90024, USA
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
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.
- 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.
- 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.
All your information will be kept confidential according to EEO guidelines.