Regulatory Compliance Lead

Verily•Boston, MA

2d•$111,000 - $167,000

About The Position

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.

Requirements

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

Nice To Haves

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).

Responsibilities

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.