Courtney Smith

About Courtney Smith

Strategic executive delivering enterprise-wide quality and regulatory leadership across complex global medical device portfolios. Known for enabling accelerated market access, strengthening inspection readiness, and driving sustained operational excellence in highly regulated environments. Demonstrated success advancing design control rigor, process optimization, and full product lifecycle compliance aligned with US and European regulatory frameworks. Extensive expertise shaping IDE strategy, governing clinical investigations, and integrating post-market surveillance to ensure safe, effective, and timely product commercialization. Recognized for aligning engineering, marketing, and quality organizations to streamline regulatory pathways, support innovation, and maintain uncompromising compliance standards. Experienced in transforming regulatory and quality functions into strategic business enablers that support growth, scalability, and performance. Results-driven leader of global teams, building cultures grounded in accountability, technical excellence, and continuous improvement. Trusted partner to executive leadership in navigating evolving regulatory landscapes, strengthening risk governance, and advancing global market access strategies.

Experience

1. Senior Director Regulatory Affairs

   Convatec

   Jan 2022 — Present · Lexington, MA, US

   My core day-to-day tasks in this role included:• Overseeing regulatory operations across three business units to ensure compliance and operational excellence• Designing, communicating, and reporting global regulatory strategy and project prioritization to cross-functional leadership• Leading creation, submission, and lifecycle management of regulatory documentation for new products and modifications• Approving post-market surveillance activities including Medical Device Reporting, safety alerts, and field action policiesA section of my key accomplishments in this capacity entails:• Initiated and supervised continuous improvement initiatives, including regulatory master data management, change control, and implementation of a standardized labeling compendium across all business units.• Led implementation of EU MDR compliance across two business units and adhered to updated European regulatory standards.• Partnered with R&D, Quality, Legal, and Compliance teams to align regulatory requirements with business objectives.• \\Advised on domestic and international compliance and streamlined registrations to meet regulatory requirements efficiently.• Established regulatory operations branch to centralize global registrations, regulatory intelligence, and advertising/MRL oversight.• Enhanced competency and operational readiness by reengineering training and professional development programs for the Regulatory Department.

Education

• Walla Walla University

  Bachelor’s Degree, Biology (Chemistry)

• Kansas State University

  Master’s Degree, Anatomy and Physiology

Skills

• Spine
• Ce Marking
• Design Control
• Biomedical Engineering
• Orthopedic
• Iso 13485
• Orthopedics
• Fda
• Surgeons
• Capital Equipment
• Medical Devices
• Microsoft Office
• Surgical Instruments