Monika McDole-Russell

About Monika McDole-Russell

As a seasoned regulatory affairs executive with extensive global experience in Class II and medical devices—including AI/ML and software-enabled device technologies—I bring a rare blend of strategic insight, regulatory depth, and operational excellence. My leadership has guided cross-functional teams across continents, secured timely global approvals, and shaped regulatory strategy at the highest organizational levels.I am adept at navigating complex global regulatory environments and influencing enterprise-wide decisions as a trusted advisor on executive leadership teams. I’ve successfully led regulatory strategies for portfolios exceeding 25 products, driven multi-million dollar budget efficiency, and directly engaged with agencies such as the FDA and EU Notified Bodies. My collaborative, outcomes-focused approach consistently accelerates market access, mitigates risk, and fuels innovation in highly regulated domains.I thrive at the intersection of technical rigor and business alignment—driving scalable regulatory frameworks that enable growth, strengthen compliance, and empower high-performing teams. As a committed advocate for gender equity in STEMM, I’m dedicated to elevating underrepresented voices and creating a more inclusive, innovative future for all.

Experience

1. Sr Director, Global Regulatory Intelligence and Advertising Promotion

   Intuitive

   Oct 2025 — Present · Sunnyvale, CA, US

   As Sr. Director of Global Regulatory Intelligence and Advertising & Promotion, I lead the strategic expansion of Intuitive’s global regulatory intelligence capabilities, positioning the organization to proactively navigate evolving regulatory frameworks across international markets.My role is centered on shaping and executing a forward-looking strategy that integrates global standards and regulatory requirements into our commercial operations. I work across regions and functions to ensure our regulatory intelligence infrastructure supports both current needs and future growth, enabling informed decision-making and sustained compliance.I also oversee the global regulatory advertising and promotion function, guiding the development and review of product communications to ensure alignment with regulatory expectations. This includes chairing cross-functional committees, collaborating with clinical and marketing teams, and driving process optimization to support compliant and effective messaging.A key part of my role involves representing Intuitive Surgical—a world leader in surgical robotics—in international forums to help shape global regulations and standards. This work is driven by our commitment to ensuring that safe and effective medical devices reach as many patients as possible, while advancing regulatory frameworks that serve both innovation and public health.Through external engagement and internal leadership, I help ensure Intuitive remains at the forefront of regulatory excellence and global impact.

Education

• Northeastern University

  Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics, and Medical Devices

• Temple University

  Bachelor's, Communications

• Harvard University

  Professional Certificate in Computer Science for Artificial Intelligence, Computer Science

Skills

• Design Control
• Biologics
• Validation
• Editing
• Iso 13485
• Orthopedics
• Fda
• Regulatory Affairs
• Orthopedic
• Writing
• Regulatory Submissions
• Corrective and Preventive Action (Capa)
• 21 Cfr Part 11
• Product Launch
• 510(K)
• U.s. Food and Drug Administration (Fda)
• Biomaterials
• Iso 14971
• Manufacturing
• R&D
• Commercialization
• Project Management
• Clinical Trials
• Medical Devices
• Capa
• Quality System
• V&V
• Biomedical Engineering
• Change Control
• U.s. Title 21 Cfr Part 11 Regulation
• Biotechnology
• Ce Marking
• Research and Development (R&D)
• Medical Device Directive
• Software Documentation
• Verification and Validation (V&V)
• Gmp