Regulatory Affairs Manager

@ Curai Health

About Curai Health

Curai Health is pioneering a new model of primary care unlocked by AI. By deploying machine learning into clinical workflows, Curai delivers affordable, quality primary care while partnering with insurers to keep patients engaged.

Regulatory Affairs at Curai

The Regulatory Affairs Manager will help implement and maintain foundational systems for quality management and AI governance. You will work closely with product, engineering, clinical, and compliance teams to ensure AI systems are safe, compliant, and scalable.

What You’ll Do

• Deliver foundational infrastructure for clinical AI governance and regulatory readiness.
• Stand up and maintain the Quality Management System (QMS) including documentation, change management and process controls.
• Operationalize the AI governance framework using standards like the NIST AI Risk Management Framework.
• Write and update SOPs, traceability documents, and risk logs.
• Drive internal audit readiness and manage quality events.
• Collaborate with product, engineering, and clinical teams to design lightweight, effective workflows.
• Implement compliance-minded process changes and monitor new systems.
• Lead documentation efforts and facilitate change rollouts across teams.

What You’ll Need

• 3+ years experience in quality, compliance, regulatory, or technical program management.
• Experience with QMS systems and FDA documentation workflows.
• Strong technical fluency to follow ML, product development, and system design discussions.
• Excellent written and verbal communication skills with high attention to detail.
• Preferred: ISO 13485, FDA SaMD regulations, or AI governance framework experience.

What We Offer

• Mission-driven culture with collaborative, high-caliber teammates.
• Competitive compensation including stock grants.
• Unlimited PTO, flexible hours, and remote work options.
• Excellent medical, dental, vision benefits and 401k with matching.

Key skills/competency

• Quality Management
• AI Governance
• Regulatory
• Compliance
• QMS
• SOP
• Audit
• Documentation
• Change Management
• Risk Management