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Skills: Regulatory Compliance, SaMD, AI/ML Compliance, FDA Regulations, ISO 13485
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Boston, Massachusetts, United States · Hybrid
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Develop and maintain regulatory compliance frameworks for consumer, research, and medical device products, specifically focusing on AI/ML and generative AI applications. Partner with engineering and product teams to operationalize US and international regulatory requirements throughout the product development lifecycle.
Requires a Bachelor's degree in a quantitative field and 5+ years of regulatory affairs experience in medical devices or digital health. Must have technical expertise in SaMD, FDA guidance, and proficiency with software development tools like Jira and GitHub.
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 Verily's product portfolio grows.
Minimum 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.
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 $111,000 - $167,000 + 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 you'd 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.
Verily Health is a data platform and technology company purpose-built to power AI-enabled precision health. We combine deep clinical, regulatory, and technological expertise to provide our customers with patient-centric solutions that make healthcare more personal and precise. Verily solutions are designed to make healthcare data AI-ready and fit for purpose across care, research, and public health. For more information about Verily please visit: verily.com. Verily is hiring! Check out what's available globally at verily.com/careers.
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Based on 1842 listings with disclosed salaries, most data & analytics jobs in Boston, MA pay between $85k–$215k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 2,194 open data & analytics positions in Boston, MA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include State Street, WHOOP, Liberty Mutual Insurance, Publicis Groupe Holdings B.V., Fidelity Investments, among others. Browse the listings above to see every active employer.
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