VoxelCloud, Inc. logoVoxelCloud, Inc. logo

Vice President of Regulatory Affairs

VoxelCloud, Inc.Los Angeles
On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

A demonstrated commitment to enhancing healthcare outcomes. A minimum of 5 years of proven experience in navigating health software through the FDA clearance process, including registration, pre-submission, 510(k), De Novo, and CE mark processes. Experience with diagnostic AI software is highly desirable. Prior experience in a startup environment is advantageous. A robust network of contacts within the regulatory affairs field that can be utilized to establish best practices and anticipate regulatory shifts. Comprehensive understanding of the U. S. healthcare landscape. A strong track record of collaboration with cross-functional teams and effective communication with regulatory authorities and stakeholders. Exceptional communication, presentation, and leadership capabilities. Excellent organizational and time management skills, with a keen attention to detail.

About the job

VoxelCloud is on the lookout for a dynamic and accomplished Vice President of Regulatory Affairs to lead our regulatory strategies and initiatives across all FDA-related processes throughout the lifecycle of our innovative medical imaging software solutions. This pivotal role involves direct engagement with the FDA, external legal counsel, and various stakeholders to ensure compliance and effective communication of our regulatory matters.

The successful candidate will play a crucial role in our executive team, collaborating closely with internal departments to expedite the market introduction of cutting-edge AI technologies designed for medical imaging. Additionally, this VP will be responsible for shaping, monitoring, and enhancing VoxelCloud's regulatory compliance framework.

  • Formulate and implement VoxelCloud's regulatory strategy, aligning with corporate objectives while assessing business risks and budget considerations.

  • Efficiently manage all FDA regulatory activities across the company, particularly concerning our software as a medical device (SaMD) offerings.

  • Act as a credible and influential spokesperson, representing VoxelCloud to regulatory bodies during pre-submission and submission processes, while articulating the advantages and developmental protocols of our AI-driven medical imaging solutions.

  • Oversee the preparation of regulatory submissions and compliance evaluations.

  • Coordinate internal and external audit processes.

  • Offer regulatory insights for new product development and clinical trial methodologies.

  • Stay informed on industry trends, regulatory changes, and legal factors, providing strategic guidance accordingly.

About VoxelCloud, Inc.

Founded in 2016, VoxelCloud, Inc. is a leading innovator in the AI analysis of medical imaging and video, headquartered in Los Angeles. Our solutions empower healthcare professionals to make timely and informed diagnoses, ultimately enhancing patient outcomes. We currently focus on critical areas such as oncology, cardiovascular health, and retinal diseases. Backed by prominent investors including Sequoia Capital and Tencent, VoxelCloud has raised a total of $78.5 million in Series B funding. We pride ourselves on attracting top-tier talent eager to collaborate with brilliant minds on pioneering AI software that has the potential to save lives.

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