Vice President, Regulatory Strategy and Innovation

Cleerly

Vice President of Regulatory Strategy and Innovation at Cleerly, defining the long-term regulatory vision and ensuring compliance across product portfolio.

Posted 5/1/2026full-timeRemote • California, New York, Texas • 🇺🇸 United StatesLead💰 $336,000 - $360,000 per yearWebsite

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion
Architect regulatory strategies enabling independent iteration of AI algorithms distinct from core platforms
Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning
Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework
Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency
Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities.
Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms
Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations

Requirements

What you’ll need

B.S. or higher degree in a Life Science, Engineering, or related discipline
JD preferred
Regulatory Affairs Certification (RAC) highly preferred
Minimum 15+ years of progressive Regulatory Affairs experience, including significant expertise in SaMD and AI/ML-enabled medical technologies
Minimum 7–10 years of leadership experience, including managing managers and multi-level teams
Demonstrated experience defining global regulatory strategy under EU MDR and international frameworks (including GCC markets)
Proven record of executive engagement with global regulatory authorities
Deep understanding of software development lifecycle (SDLC), agile methodologies, and application of IEC 62304 and ISO 14971 within modular and AI-enabled architectures
Experience integrating regulatory strategy into product development and commercialization planning
Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure strongly preferred

Benefits

Comp & perks

20% target annual bonus
stock options
paid benefits
employee perks

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory AffairsAI algorithmsSaMDAI/ML-enabled medical technologiesglobal regulatory strategyEU MDRIEC 62304ISO 14971software development lifecycleagile methodologies

Soft Skills

leadershipstrategic thinkingadvisory skillscommunicationteam managementrisk assessmentpolicy analysiscollaborationproblem-solvingorganizational skills

Certifications

Regulatory Affairs Certification (RAC)B.S. or higher degree in Life ScienceJD