Hiring: Regulatory Compliance Lead Company: Verily Health Location: Raleigh, NC Job Posted Time: 2026-09-16 23:42:23 Employment Type: Full-time Target Skills & Keywords : GCP, GitHub, Jira, LLM, Product Development Lifecycle, Python, R, Regulatory Compliance, Risk Management About the job Experience: •5+ years of experience in regulatory affairs within the medical device, digital health, or life sciences industry. Required Skills: •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. Qualifications: •Bachelor's 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. •Operational 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. •Applied hands-on capability in 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. •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. •Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Compensation: •$111,000 - $167,000 / year •The US base salary range for this full-time position is $111,000 - $167,000 + bonus + equity + benefits Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!