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Regulatory Compliance Lead
VerilyRegulatory Compliance Lead developing and maintaining compliance frameworks for AI-enabled health solutions. Collaborating with engineering and product teams to meet regulatory requirements.
Posted 7/21/2026full-timeDallas • California, Massachusetts, Texas • 🇺🇸 United StatesSenior💰 $111,000 - $167,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing regulatory compliance frameworks for SaMD and AI/ML-enabled products, with strong analytical and statistical skills to support regulatory decision-making. Proficient in navigating FDA guidance and ISO standards while collaborating with cross-functional teams to operationalize regulatory requirements.
Highest-signal resume keywords
Regulatory Compliance Framework DevelopmentExperience in Regulatory AffairsKnowledge of FDA GuidanceFamiliarity with ISO 13485:2016Analytical and Statistical Skills
ATS Keywords
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Hard Skills
Regulatory Compliance FrameworksStatistical MethodsQuantitative AnalysisRegulatory DocumentationPost-Market Regulatory ActivitiesRegulatory Landscape AssessmentsFDA QMSRAI/ML Regulatory EvaluationSaMD ProductsRegulatory Guidance Interpretation
Tools & Technologies
Google WorkspaceJiraGitHubDocument Control Systems
Certifications & Qualifications
RAC (US or EU)Advanced Degree in EngineeringAdvanced Degree in StatisticsAdvanced Degree in Computer Science
Industry Keywords
Medical DeviceDigital HealthLife SciencesRegulatory AffairsFDAISO 13485:2016
About the role
Key responsibilities & impact- Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer, research, and SaMD products
- Partners with engineering, product, and quality teams to operationalize regulatory requirements
- Applies statistical methods and analytical tools to support regulatory decision-making
- Supports post-market regulatory activities for AI/ML-enabled products
- Conducts regulatory landscape assessments for new products and markets
- Monitors and interprets evolving regulatory guidance
- Authors and maintains regulatory documentation
Requirements
What you’ll need- Bachelor's degree in engineering, computer science, statistics, or a related quantitative field
- 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
- Working knowledge of applicable FDA guidance including FDA QMSR
- Familiarity with ISO 13485:2016 requirements
- Proficiency with Google Workspace and software development and quality tools (Jira, GitHub, document control systems)
- Strong analytical and statistical skills with experience applying quantitative methods to regulatory evaluation
- 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.
Benefits
Comp & perks- Flexibility
- Resources
- Competitive benefits to support whole-person well being