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Cleerly

Personalized precision heart health

Vice President, Regulatory Strategy and Innovation

ComplianceComplianceOtherRemoteLeadTeam 201-500Since 2017H1B SponsorCompany SiteLinkedIn

Location

California + 2 moreAll locations: California | New York | Texas

Posted

112 days ago

Salary

$336K - $360K / year

Seniority

Lead

Bachelor Degree15 yrs expEnglishSDLC

Job Description

Vice President, Regulatory Strategy and Innovation

Cleerly

• 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, defining regulatory logic for modular systems (AI engines, reporting engines, workflow tools). • 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 (FDA, EU MDR, EU AI Act, IMDRF) and proactively assess impact. • Ensure commercial claims remain defensible, traceable to cleared indications, and aligned with global regulatory requirements. • Establish scalable processes, KPIs, and performance metrics to enhance regulatory efficiency, transparency, and predictability. • Develop and manage departmental budgets and long-range resource planning aligned with corporate growth.

Job Requirements

  • 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.
  • Strategic Foresight: Ability to synthesize complex regulatory landscapes and define clear long-term direction.
  • Courageous Leadership: Navigating ambiguity in emerging AI regulations while maintaining rigorous compliance standards.

Benefits

  • 20% target annual bonus
  • Stock options
  • Paid benefits
  • Employee perks

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