Regulatory Compliance Lead, AI/SaMD in Healthcare

Verily Health; Raleigh (NC); Vor Ort; USD 111.000 - 167.000; Vollzeit

Zusammenfassung

Verily Health is seeking a Regulatory Compliance Lead to shape and maintain regulatory frameworks across consumer, research, and SaMD products. You will collaborate with engineering and product teams to embed US regulatory requirements into the development lifecycle and plan for potential ex-US expansion.

You will apply statistical methods, manage submissions and design controls, and monitor post-market performance for AI/ML-enabled devices, ensuring alignment with FDA guidance and ISO 13485

Qualifikationen

• Bachelor's degree in engineering, CS, statistics, or related quantitative field with 5+ years in regulatory affairs.
• Experience building regulatory frameworks for SaMD/AI/ML-enabled products with FDA QMSR familiarity, ISO 13485:2016, ISO 14971, IEC 62304.
• Proficiency with Google Workspace, Jira, GitHub, and document control systems to operationalize compliance within engineering workflows.
• Strong analytical and statistical skills applied to regulatory evaluation, performance monitoring, or post-market surveillance.

Aufgaben

• Develops and maintains regulatory frameworks for consumer, research, and SaMD products aligned with US regulations and ex-US expansion.
• Partners with engineering, product, and quality teams to operationalize requirements using Jira, GitHub, Google Workspace, and document control systems.
• Applies statistical methods to regulatory decisions, post-market surveillance, and model drift assessment for AI/ML-enabled products.
• Conducts regulatory landscape assessments for new products/markets and translates requirements into actionable processes for cross-functional teams.
• Authors and maintains regulatory documentation including submissions and SOPs per ISO 13485:2016; supports regulatory interactions and relationships with regulators.

Kenntnisse

Regulatory affairs

Statistical analysis

Cross-functional collaboration

Quality systems

Ausbildung

Bachelor's degree in engineering, CS, statistics or related field

MS/PhD or RAC certification

Tools

Google Workspace

Jira

GitHub

Document control systems

Jobbeschreibung

Verily Health is seeking a Regulatory Compliance Lead to shape and maintain regulatory frameworks across consumer, research, and SaMD products. You will collaborate with engineering and product teams to embed US regulatory requirements into the development lifecycle and plan for potential ex-US expansion.

You will apply statistical methods, manage submissions and design controls, and monitor post-market performance for AI/ML-enabled devices, ensuring alignment with FDA guidance and ISO 13485