The Regulatory Affairs Manager will implement and maintain foundational systems for AI governance and regulatory readiness, collaborating with cross-functional teams to ensure compliance while promoting speed and efficiency.
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. Easy-to-use and convenient, Curai Health partners with insurers to keep patients engaged in their care over time, improving health outcomes and reducing costs.
Our company is remote-first, and we consider candidates across the United States. Our corporate office is located in San Francisco.
Regulatory Affairs at Curai
Curai’s AI systems sit at the heart of how we deliver care—and we’re investing in the infrastructure to make those systems safe, compliant, and ready to scale. As we move toward our vision of building fully autonomous clinical agents, we are installing foundational systems for quality management and AI governance.
We are hiring a Regulatory Affairs Manager to help implement and maintain these systems. This person will work closely with cross-functional teams across product, engineering, clinical, and compliance to ensure our AI is responsibly built and can meet regulatory standards—without slowing down our product velocity.
Who You Are
None of these individually are hard requirements but they do describe the type of folks that we think would be most effective and happy at Curai. You…
• Believe in and are excited by our vision of a future where AI democratizes access to the highest quality healthcare in the world
• Are a natural operator with high executive function—you like implementing systems, writing things down, creating structure, and making quality practices stick
• Are confident navigating change in a fast-moving environment—you know how to earn trust while proposing process improvements
• Can speak the languages of product, engineering, and AI, and you’re comfortable in cross-functional meetings
• Care deeply about responsible, equitable AI and building trust in healthcare
• Thrive as a collaborative team member, supporting others without needing to be the loudest voice in the room
What You’ll Do
A week in the life of this Program Manager includes…
Delivering foundational infrastructure for clinical AI governance and regulatory readiness
• Standing up and maintaining our Quality Management System (QMS), including version-controlled documentation, change management, and process controls
• Operationalizing our AI governance framework, starting with the NIST AI Risk Management Framework
• Writing, revising, and maintaining key SOPs, traceability documents, and risk logs
• Driving internal audit readiness and quality events when necessary
Ensuring new process layers don’t slow us down
• Embedding yourself with product, engineering, and clinical teams to align on “just enough” governance
• Designing and implementing workflows that enhance quality while preserving Curai’s speed
• Keeping documentation lightweight and processes humane—this is a startup, after all
Acting as the responsible individual for compliance-minded process change
• Working autonomously to implement new systems and tools to support QMS and AI governance
• Coordinating inputs across multiple stakeholders (including AI team, engineers, and PMs)
• Monitoring effectiveness of newly implemented practices and iterating accordingly
Collaboration with colleagues
• Leading documentation efforts in partnership with product, clinical, and engineering
• Supporting product teams through change rollouts, onboarding to new processes, and feedback loops
• 1:1s with your manager and collaborators across engineering, clinical operations, and product
What You’ll Need
Must have
• 3+ years of experience in quality, compliance, regulatory, or technical program management
• Experience working within QMS systems and FDA documentation workflows
• Demonstrated success implementing structured processes in a fast-paced or startup environment
• Basic technical fluency—you can follow discussions on ML, product dev, and system design
• Clear, confident written and verbal communication skills
• Highly organized with strong attention to detail
Nice to have
• Experience with ISO 13485, FDA SaMD regulations, or AI governance frameworks (e.g., NIST AI RMF)
• Healthcare, medtech, or regulated tech environment experience
• Direct experience managing audits or internal review processes
What We Offer
• Culture: Mission driven talent with great colleagues committed to living our values, collaborating and driving performance
• Pay: Competitive compensation and stock
• Wellness: Unlimited PTO, flexible working hours and remote working options
• Benefits: Excellent medical, dental, vision, flex spending plans, and and paid parental leave
• Financial: 401k plan with employer matching
The annual base salary range for this position is between $145,000 and $165,000 annually. Stock grants also play a key part in any offer, they increase your overall compensation package significantly based on company success. Please note that the base salary range is a guideline, and individual total compensation will vary based on qualifications, skill level, competencies, and work location.
Curai Health is a startup with a small, but world-class team from high-tech companies, AI researchers, and practicing physicians, to team members from non-traditional career paths and backgrounds. We also have research partnerships with leading universities across the country and access to medical data that facilitates research in this space. We are a highly collaborative, data-driven team, focused on delivering our mission with funding from top-tier Silicon Valley investors including Morningside, General Catalyst, and Khosla Ventures.
At Curai Health, we are highly committed to building a diverse and inclusive environment. In keeping with our beliefs and values, no employee or applicant will face discrimination or harassment based on race, color, ancestry, national origin, religion, age, gender, marital domestic partner status, sexual orientation, gender identity, disability status, or veteran status. To promote an equitable and bias-free workplace, we set competitive compensation packages for each position and do not negotiate on our offers. We are looking for mission-driven teammates, who embody our core values, and appreciate our transparent approach.
Top Skills
Ai Governance Frameworks
Fda Documentation Workflows
Iso 13485
Nist Ai Risk Management Framework
Qms Systems
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