Regulatory Compliance Lead for SaMD & AI/ML

Verily Health; Dallas (TX); On-site; USD 111,000 - 167,000; Full time

Job summary

Verily Health seeks a Regulatory Compliance Lead to develop and maintain fit-for-purpose regulatory frameworks for consumer, research, and SaMD products, including AI/ML-enabled applications, with an eye toward ex-US expansion.

You will partner with engineering, product, and quality teams to operationalize regulatory requirements throughout the product lifecycle, using Jira, GitHub, and Google Workspace for change control, submission tracking, and compliance workflows.

Qualifications

• Bachelor's degree in engineering, CS, statistics, or related field with 5+ years in regulatory affairs.
• Experience building regulatory compliance frameworks for SaMD/AI products; familiarity with FDA guidance and ISO 13485:2016.
• Proficiency with Google Workspace, Jira, GitHub, and integrating compliance into engineering workflows.
• Strong analytical and statistical skills for regulatory evaluation and post-market surveillance.

Responsibilities

• Develops regulatory frameworks for consumer, research, and SaMD products with AI/ML elements.
• Partners with engineering/product/quality to operationalize regulatory requirements in lifecycle workflows.
• Applies statistical methods to support regulatory decisions and post-market activities.
• Conducts regulatory landscape assessments and translates requirements for cross-functional teams.
• Authors regulatory docs incl. submissions and SOPs per ISO 13485:2016; supports agency interactions.

Skills

Analytical skills

Statistical methods

Education

Bachelor's degree in engineering/CS/statistics

MS/PhD or regulatory RAC certification

Tools

Jira

GitHub

Google Workspace

Job description

Verily Health seeks a Regulatory Compliance Lead to develop and maintain fit-for-purpose regulatory frameworks for consumer, research, and SaMD products, including AI/ML-enabled applications, with an eye toward ex-US expansion.

You will partner with engineering, product, and quality teams to operationalize regulatory requirements throughout the product lifecycle, using Jira, GitHub, and Google Workspace for change control, submission tracking, and compliance workflows.