Director of Clinical Affairs Endoluminal
Core
Guide and execute long-range clinical trial strategies, regulatory studies, and post-market evidence generation for Intuitive's Endoluminal Business unit.
Role type
Director of Clinical Affairs (Endoluminal)
Builds
Global clinical evidence strategies and regulatory clearance for new products and indications
Domain
Medical Devices / Endoluminal Technology / Clinical Research
Required skills
Clinical trial strategy, regulatory compliance (MDR, GCP, ISO 14155, 21 CFR), cross-functional leadership, budget management, KPI development, market intelligence
Preferred skills
Medical robotics, surgical or flexible catheter devices, operating room settings, first human use studies
Technologies
None explicitly listed
Responsibilities
Develop clinical and scientific strategies for new product development and post-market evidence; steer execution of clinical plans conforming to regulatory requirements; provide strategic guidance for global evidence strategy and reimbursement submissions; partner with regulatory agencies and external working groups; create evidence roadmaps and 3-year plans; manage year-over-year clinical trial budgets; lead and coach the Clinical Affairs team; ensure compliance with corporate and regulatory SOPs; contribute to market intelligence and review key clinical documents
Seniority
Director, strategic leadership & team management
