Director of Regulatory Affairs
Lumicity, San Francisco, CA, United States
Director, Global Regulatory Affairs & Intelligence
Location:
Bay Area, CA (Hybrid)
Function:
Regulatory & Quality
Employment Type:
Full-Time
Overview A rapidly scaling, venture-backed digital health company is seeking a Director of Global Regulatory Affairs & Intelligence to lead worldwide regulatory strategy across a growing portfolio of connected medical technologies and software-driven solutions.
This organization develops advanced diagnostic and clinical decision-support tools used by healthcare providers to improve detection, monitoring, and management of complex conditions. Its products are deployed across major health systems globally and supported by strong clinical validation and regulatory clearances.
The company is backed by leading healthcare and technology investors and is recognized for its innovation at the intersection of medical devices, AI, and software.
Position Summary This role is responsible for defining and executing global regulatory strategy across both hardware and software-based medical technologies. The Director will oversee regulatory planning from early-stage development through commercialization, ensuring timely approvals while maintaining full compliance with evolving international standards.
This individual will play a critical role in integrating regulatory considerations into product development, enabling efficient market entry, and supporting long‑term business growth across multiple geographies.
Key Responsibilities
Own the global regulatory strategy across the product portfolio, aligning regulatory pathways with broader company objectives and market priorities
Lead preparation and submission of regulatory filings including FDA (510(k), De Novo), CE Mark under EU MDR, Health Canada, and other international jurisdictions
Act as the primary liaison with regulatory authorities, managing communications such as pre‑submissions, deficiency responses, and inspections
Partner closely with cross‑functional teams including R&D, Clinical, Quality, Product, and Commercial to ensure regulatory requirements are incorporated early in development
Work alongside Quality leadership to ensure the Quality Management System supports compliance, audit readiness, and post‑market obligations
Develop and maintain a forward‑looking regulatory intelligence function to monitor changes in global frameworks, including AI/ML regulations, and translate insights into actionable strategies
Build, mentor, and scale a high‑performing regulatory team while establishing efficient and repeatable submission processes
Ensure compliance with all applicable regulatory standards related to clinical evaluation, labeling, safety reporting, and lifecycle management
Contribute to organizational planning by advising leadership on regulatory risks, timelines, and opportunities
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related technical field, advanced degree preferred
10+ years of experience in regulatory affairs within the medical device industry, including both hardware and software-based products
Demonstrated success leading regulatory submissions and securing approvals in the U.S. and international markets
Deep understanding of global regulatory frameworks including FDA pathways, EU MDR, ISO 13485, and MDSAP
Proven experience managing interactions with regulatory agencies and successfully navigating inspections and reviews
Strong ability to interpret evolving regulations, especially in areas such as AI, cybersecurity, and software validation
Experience leading regulatory teams in fast‑paced, innovation‑driven environments
Familiarity with regulatory and quality systems such as Veeva Vault, MasterControl, or similar platforms
Excellent communication skills with the ability to influence cross‑functional stakeholders and executive leadership
Preferred Experience
Advanced degree (MS, PhD, MBA, or RAC certification) in a relevant discipline
Background in AI-enabled or software‑driven medical technologies
Experience with emerging regulatory frameworks related to machine learning and adaptive algorithms
Track record of supporting novel regulatory pathways, including first‑of‑kind or breakthrough technologies
Exposure to reimbursement strategy or collaboration with health economics teams
Experience in high‑growth or early‑stage companies building regulatory infrastructure from the ground up
Familiarity with EU MDR requirements including PRRC responsibilities
Experience developing clinical evaluation strategies and supporting global claims
Hybrid work model with regular in‑office collaboration
Primarily desk‑based with extended periods of computer work
Ability to perform essential functions with or without accommodation
Competitive base salary aligned with market benchmarks
Equity participation
401(k) with company match
Generous paid time off and parental leave
#J-18808-Ljbffr
Location:
Bay Area, CA (Hybrid)
Function:
Regulatory & Quality
Employment Type:
Full-Time
Overview A rapidly scaling, venture-backed digital health company is seeking a Director of Global Regulatory Affairs & Intelligence to lead worldwide regulatory strategy across a growing portfolio of connected medical technologies and software-driven solutions.
This organization develops advanced diagnostic and clinical decision-support tools used by healthcare providers to improve detection, monitoring, and management of complex conditions. Its products are deployed across major health systems globally and supported by strong clinical validation and regulatory clearances.
The company is backed by leading healthcare and technology investors and is recognized for its innovation at the intersection of medical devices, AI, and software.
Position Summary This role is responsible for defining and executing global regulatory strategy across both hardware and software-based medical technologies. The Director will oversee regulatory planning from early-stage development through commercialization, ensuring timely approvals while maintaining full compliance with evolving international standards.
This individual will play a critical role in integrating regulatory considerations into product development, enabling efficient market entry, and supporting long‑term business growth across multiple geographies.
Key Responsibilities
Own the global regulatory strategy across the product portfolio, aligning regulatory pathways with broader company objectives and market priorities
Lead preparation and submission of regulatory filings including FDA (510(k), De Novo), CE Mark under EU MDR, Health Canada, and other international jurisdictions
Act as the primary liaison with regulatory authorities, managing communications such as pre‑submissions, deficiency responses, and inspections
Partner closely with cross‑functional teams including R&D, Clinical, Quality, Product, and Commercial to ensure regulatory requirements are incorporated early in development
Work alongside Quality leadership to ensure the Quality Management System supports compliance, audit readiness, and post‑market obligations
Develop and maintain a forward‑looking regulatory intelligence function to monitor changes in global frameworks, including AI/ML regulations, and translate insights into actionable strategies
Build, mentor, and scale a high‑performing regulatory team while establishing efficient and repeatable submission processes
Ensure compliance with all applicable regulatory standards related to clinical evaluation, labeling, safety reporting, and lifecycle management
Contribute to organizational planning by advising leadership on regulatory risks, timelines, and opportunities
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related technical field, advanced degree preferred
10+ years of experience in regulatory affairs within the medical device industry, including both hardware and software-based products
Demonstrated success leading regulatory submissions and securing approvals in the U.S. and international markets
Deep understanding of global regulatory frameworks including FDA pathways, EU MDR, ISO 13485, and MDSAP
Proven experience managing interactions with regulatory agencies and successfully navigating inspections and reviews
Strong ability to interpret evolving regulations, especially in areas such as AI, cybersecurity, and software validation
Experience leading regulatory teams in fast‑paced, innovation‑driven environments
Familiarity with regulatory and quality systems such as Veeva Vault, MasterControl, or similar platforms
Excellent communication skills with the ability to influence cross‑functional stakeholders and executive leadership
Preferred Experience
Advanced degree (MS, PhD, MBA, or RAC certification) in a relevant discipline
Background in AI-enabled or software‑driven medical technologies
Experience with emerging regulatory frameworks related to machine learning and adaptive algorithms
Track record of supporting novel regulatory pathways, including first‑of‑kind or breakthrough technologies
Exposure to reimbursement strategy or collaboration with health economics teams
Experience in high‑growth or early‑stage companies building regulatory infrastructure from the ground up
Familiarity with EU MDR requirements including PRRC responsibilities
Experience developing clinical evaluation strategies and supporting global claims
Hybrid work model with regular in‑office collaboration
Primarily desk‑based with extended periods of computer work
Ability to perform essential functions with or without accommodation
Competitive base salary aligned with market benchmarks
Equity participation
401(k) with company match
Generous paid time off and parental leave
#J-18808-Ljbffr