SaMD & AI/ML Regulatory Lead

Verily Health; San Bruno (CA); On-site; USD 111,000 - 167,000; Full time

Job summary

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

You will partner with engineering and product teams to operationalize requirements using Jira, GitHub, Google Workspace, and document controls while applying FDA QMSR and ISO 13485:2016 standards.

Qualifications

• Bachelor's degree + 5+ years regulatory affairs in medical device/digital health.
• Experience developing regulatory frameworks for SaMD/AI/ML with FDA guidance; ISO 13485 familiarity.
• Proficiency with Jira, GitHub and document control; integrate with engineering workflows.
• Strong analytical and statistical skills for regulatory evaluation and PMS.

Responsibilities

• Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer, research, and SaMD products.
• Partners with engineering, product, and quality teams to operationalize regulatory requirements using modern tools.
• Applies statistical methods to support regulatory decision-making and PMS planning.
• Conducts regulatory landscape assessments and translates requirements into actionable processes.
• Authors and maintains regulatory documentation including submissions and SOPs.

Skills

Regulatory frameworks SaMD

AI/ML regulatory

FDA QMSR guidance

Statistical methods

GxP risk mgmt

Education

Bachelor's degree in engineering/quantitative field

Tools

Jira

GitHub

Google Workspace

Document control systems

Job description

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

You will partner with engineering and product teams to operationalize requirements using Jira, GitHub, Google Workspace, and document controls while applying FDA QMSR and ISO 13485:2016 standards.