Regulatory Compliance Lead

Verily Health is a data platform and technology company purpose-built to power AI-enabled precision health solutions that accelerate research and improve care for individuals and communities. Uniquely positioned at the intersection of technology data science and healthcare Verily transforms multimodal health data into insights models and actions that make healthcare more personalized predictive and precise.

The Regulatory Compliance Lead is a technically grounded individual contributor responsible for developing and maintaining fit-for-purpose regulatory compliance frameworks across consumer research and medical device (SaMD) product areas. This role partners closely with engineering and product teams to operationalize US regulatory requirements with an eye toward ex-US expansion leveraging tools such as Jira GitHub and document control systems to embed compliance into the product development lifecycle.

• Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer research and SaMD products including AI/ML-enabled and generative AI applications in alignment with applicable US regulations and with an eye toward ex-US expansion.

• Partners with engineering product and quality teams to operationalize regulatory requirements throughout the product development lifecycle leveraging Google Workspace Jira GitHub and document control systems for change control submission tracking and compliance workflows.

• Applies statistical methods and analytical tools to support regulatory decision-making including performance evaluation clinical equivalence assessments and threshold analysis for regulated products. Supports post-market regulatory activities for AI/ML-enabled products including real-world performance monitoring algorithmic change assessment post-market surveillance (PMS) planning and evaluation of model drift or output degradation against predefined regulatory thresholds.

• Conducts regulatory landscape assessments for new products and markets identifying compliance risks and opportunities and developing proactive mitigation strategies to maintain a strong regulatory posture. Monitors and interprets evolving regulatory guidance including FDA SaMD AI/ML and predetermined change control plan (PCCP) frameworks and translates requirements into actionable processes and procedures for cross-functional teams.

• Authors and maintains regulatory documentation including submissions SOPs and Design and Development File content per ISO 13485:2016 supporting both pre-market and post-market compliance activities. Supports regulatory interactions and maintains awareness of agency expectations across applicable product domains; contributes to building positive relationships with regulatory bodies as Verilys product portfolio grows.

Minimum Qualifications

• Bachelors degree in engineering computer science statistics or a related quantitative field with 5 years of experience in regulatory affairs within the medical device digital health or life sciences industry.

• Demonstrated technical experience developing regulatory compliance frameworks for SaMD and/or AI/ML-enabled products with working knowledge of applicable FDA guidance including FDA QMSR and familiarity with ISO 13485:2016 requirements risk management processes per ISO 14971 and medical device software lifecycle processes per IEC 62304.

• Proficiency with Google Workspace and software development and quality tools including Jira GitHub and document control systems with the ability to work directly within engineering workflows to operationalize compliance requirements.

• Strong analytical and statistical skills with experience applying quantitative methods to regulatory evaluation performance monitoring or post-market surveillance activities.

Preferred Qualifications

• Experience with AI/ML-enabled medical device products including familiarity with FDA AI/ML SaMD guidance predetermined change control plans (PCCP) and post-market performance monitoring for generative AI applications; experience using generative AI tools (e.g. Claude ChatGPT) to enhance regulatory and compliance workflows is a plus.

• Familiarity with MDSAP audit programs and/or international regulatory frameworks (e.g. EU MDR Health Canada TGA) in support of ex-US market expansion. Experience supporting regulatory compliance across regulated research programs including GCP and/or GCLP environments clinical studies or laboratory-developed products.

• Hands-on experience with post-market surveillance and vigilance activities for LLM or AI/ML-enabled products including real-world performance monitoring algorithmic change assessment and predetermined change control plan (PCCP) implementation.

• Experience applying statistical analysis tools (e.g. Python R or equivalent) to regulatory datasets including performance benchmarking signal detection or equivalence testing in a regulated product context.

• Advanced degree (MS PhD) in engineering statistics computer science or a related quantitative field or a recognized regulatory certification such as RAC (US or EU).

Qualified applicants must not require employer sponsored work authorization now or in the future for employment in the United States.

The US base salary range for this full-time position is $111000 - $167000 bonus equity benefits. Our salary ranges are determined by role level and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only and do not include bonus equity or benefits.

Verily Health Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status. For our EEO Policy Statement please click here. If youd like more information on your EEO rights under the law please click here.

If you have a need that requires accommodation please let us know by completing our Accommodations for Applicants form.