Regulatory Compliance Lead

• 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

• 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.

Core Competencies

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 Development
• Experience in Regulatory Affairs
• Knowledge of FDA Guidance
• Familiarity with ISO 13485:2016
• Analytical and Statistical Skills

ATS Optimization Keywords

Hard Skills

• Regulatory Compliance Frameworks
• Statistical Methods
• Quantitative Analysis
• Regulatory Documentation
• Post-Market Regulatory Activities
• Regulatory Landscape Assessments
• FDA QMSR
• AI/ML Regulatory Evaluation
• SaMD Products
• Regulatory Guidance Interpretation

Certifications & Qualifications

• RAC (US or EU)
• Advanced Degree in Engineering
• Advanced Degree in Statistics
• Advanced Degree in Computer Science

Industry Keywords

• Medical Device
• Digital Health
• Life Sciences
• Regulatory Affairs
• FDA
• ISO 13485:2016

Tools & Technologies

• Google Workspace
• Jira
• GitHub
• Document Control Systems