Director Clinical Affairs
Core
Develop and execute clinical study strategies and plans to support premarket and postmarket clinical evidence needs for Intuitive products in European markets.
Role type
Director, Clinical Affairs (Strategy & Team Leadership)
Builds
Clinical evidence strategies, outcomes research studies, manuscripts, registries, and scientific evidence generation with medical/surgical societies.
Domain
Medical Devices / Surgical Robotics / Clinical Research
Required skills
Clinical study strategy, cross-functional collaboration, team leadership, regulatory compliance (GCP, EU MDR), KOL relationship management, project management, evidence appraisal
Preferred skills
Surgical robotics and endoscopic surgery experience, fluency in European languages, advanced degree (MD, MS, PhD)
Technologies
GCP, ISO 14155, EU MDR, US FDA regulations
Responsibilities
Drive clinical evidence strategies for European markets; oversee company-sponsored, collaborative, and investigator-initiated studies; build relationships with KOLs and medical societies; review and approve clinical documents (CIP, CSR, PMCF); hire and develop clinical affairs staff; ensure regulatory compliance; provide leadership to the broader Clinical Affairs organization.
Seniority
Director, strategic leadership with people management