Vice President, Regulatory Strategy and Innovation

Role Overview

• 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.

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.

Tech Stack

• SDLC

Benefits

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