Regulatory Affairs Manager - Remote

Overview

Curai Health is pioneering a new model of primary care, unlocked by AI, to address the biggest challenges in care delivery. By deploying machine learning into clinical workflows, Curai enables its dedicated, specially trained clinicians to deliver primary care to more people at a fraction of the cost.

In Short

• Help implement and maintain regulatory systems for AI governance.
• Work with cross-functional teams including product, engineering, and clinical.
• Stand up and maintain Quality Management System (QMS).
• Operationalize AI governance framework.
• Write and manage key SOPs and risk logs.
• Ensure compliance-minded process changes.
• Collaborate with product and engineering teams.
• 3+ years of experience in quality or regulatory management.
• Experience in fast-paced or startup environments.
• Competitive compensation and benefits offered.

Requirements

• 3+ years of experience in quality, compliance, or regulatory management.
• Experience with QMS systems and FDA documentation.
• Strong organizational skills and attention to detail.
• Clear written and verbal communication skills.
• Basic technical fluency in ML and system design.
• Experience with ISO 13485 or AI governance frameworks is a plus.
• Healthcare or regulated tech experience is preferred.

Benefits

• Unlimited PTO and flexible working hours.
• Excellent medical, dental, and vision benefits.
• 401k plan with employer matching.
• Stock grants based on company success.
• Diverse and inclusive workplace culture.