Professional Timeline

Valar Labs

• Lead regulatory strategy for an AI-powered diagnostics platform
• Built the company's first regulatory function and quality processes
• Own FDA strategy across SaMD classification and De Novo planning

Artera

• Led a significant regulatory authorization for a novel AI diagnostic
• Managed FDA interactions and submission strategy end-to-end
• Partnered with engineering and clinical teams on AI/ML documentation

Prior healthcare organization

• Supported regulatory submissions across diagnostics and oncology
• Developed early expertise in software as a medical device (SaMD)