Regulatory Compliance Lead (AI/ML SaMD)

Location: Dallas, Texas, United States

Salary: $111,000–$167,000 per year base salary, plus bonus, equity, and benefits

Company

hirify.global Health is a data platform and technology company developing AI-enabled precision health solutions across technology, data science, and healthcare.

What you will do

• Develop and maintain regulatory compliance frameworks for consumer, research, and SaMD products, including AI/ML-enabled and generative AI applications.
• Partner with engineering, product, and quality teams to embed US regulatory requirements into the product development lifecycle using Google Workspace, Jira, GitHub, and document control systems.
• Apply statistical and analytical methods to support performance evaluation, clinical equivalence assessments, threshold analysis, and regulatory decision-making.
• Support post-market activities for AI/ML-enabled products, including real-world performance monitoring, algorithmic change assessment, PMS planning, and model-drift evaluation.
• Assess regulatory landscapes for new products and markets, interpret FDA SaMD, AI/ML, and PCCP guidance, and develop mitigation strategies.
• Author regulatory submissions, SOPs, and Design and Development File content while supporting regulatory interactions.

Requirements

• Bachelor’s degree in engineering, computer science, statistics, or a related quantitative field and 5+ years of regulatory affairs experience in medical devices, digital health, or life sciences.
• Technical experience developing compliance frameworks for SaMD or AI/ML-enabled products.
• Working knowledge of FDA guidance, FDA QMSR, ISO 13485:2016, ISO 14971, and IEC 62304.
• Proficiency with Google Workspace, Jira, GitHub, and document control systems, with the ability to work directly in engineering workflows.
• Strong analytical and statistical skills applied to regulatory evaluation, performance monitoring, or post-market surveillance.
• Must not require employer-sponsored work authorization now or in the future for employment in the United States.

Nice to have

• Experience with FDA AI/ML SaMD guidance, PCCP, generative AI applications, and post-market performance monitoring.
• Familiarity with MDSAP, EU MDR, Health Canada, TGA, GCP, or GCLP environments.
• Experience with statistical tools such as Python or R for benchmarking, signal detection, or equivalence testing.
• Advanced degree or regulatory certification such as RAC.

Culture & Benefits

• Work at the intersection of technology, data science, and healthcare.
• Full-time employment with bonus, equity, and benefits.
• Opportunity to support product expansion into markets outside the United States.