Director, Clinical Development

Director of Surgical Clinical Development leading global strategies for ophthalmic surgical devices, including IOLs, lasers, and phacoemulsification systems.

• oversee clinical trial design and execution from early feasibility to post-market studies
• develop and author regulatory and clinical documentation
• ensure alignment with global regulatory agencies (FDA, EU MDR, NMPA, PMDA)
• collaborate with R&D, Regulatory, Quality, and Commercial teams
• manage relationships with KOLs and external stakeholders
• support regulatory submissions and market-expansion efforts
• oversee study operations, budgets, and risk mitigation

• advanced degree (MD, OD, PhD)
• 7+ years in medical device clinical development, especially ophthalmology
• proven leadership in global regulatory submissions
• deep knowledge of GCP, ISO 14155, and international regulatory frameworks
• experience with pivotal and post-market studies, registries, and real-world evidence strategies
• strong leadership, communication, and cross-functional collaboration skills

• ophthalmic surgical devices
• global regulatory strategy
• clinical evidence generation
• early feasibility through post-market
• remote work with US-based location