Senior Regulatory Lead for SaMD & AI/ML Compliance

Verily Health; Boston (MA); On-site; USD 111,000 - 167,000; Full time

Job summary

Verily Health is seeking a Regulatory Compliance Lead to develop and maintain fit-for-purpose regulatory frameworks across consumer, research, and SaMD products, including AI/ML-enabled solutions. You will partner with engineering and product teams to operationalize US regulatory requirements with an eye toward ex-US expansion.

Role requires 5+ years in regulatory affairs within medical devices or digital health; proficiency with Jira, GitHub, and document-control workflows is essential. база

Qualifications

• Bachelor’s degree in engineering, computer science, statistics, or related quantitative field with 5+ years of regulatory affairs experience.
• Demonstrated experience building regulatory compliance frameworks for SaMD/AI–ML products and familiarity with FDA guidance (QMSR) and ISO 13485:2016.
• Proficiency with Google Workspace, Jira, GitHub, and document-control systems to embed compliance in product workflows.

Responsibilities

• Develop and maintain regulatory compliance frameworks for consumer, research, and SaMD products, including AI/ML-enabled apps, aligned with US regulations and international expansion.
• Collaborate with engineering and product teams to implement regulatory requirements across the lifecycle using Jira, GitHub, and document-control tools.
• Apply statistical methods to support regulatory decisions, surveillance, and post‑market assessments for AI/ML-enabled products.
• Conduct landscape assessments, identify risks, and translate requirements into actionable processes for cross-functional teams.
• Author and maintain regulatory documentation (SOPs, submissions, DD File content) per ISO 13485:2016; engage with regulatory bodies as needed.

Skills

Regulatory affairs

AI/ML SaMD regulatory

Regulatory frameworks

Statistical analysis

Education

Bachelor’s degree in engineering, computer science, statistics

Tools

Jira

GitHub

Google Workspace

Job description

Verily Health is seeking a Regulatory Compliance Lead to develop and maintain fit-for-purpose regulatory frameworks across consumer, research, and SaMD products, including AI/ML-enabled solutions. You will partner with engineering and product teams to operationalize US regulatory requirements with an eye toward ex-US expansion.

Role requires 5+ years in regulatory affairs within medical devices or digital health; proficiency with Jira, GitHub, and document-control workflows is essential. база