Director, Clinical Development

Role: Director of Surgical Clinical Development leading global strategies for ophthalmic surgical devices, including IOLs, lasers, and phacoemulsification systems. Responsibilities: 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. Requirements: 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. HighValue: ophthalmic surgical devices, global regulatory strategy, clinical evidence generation, early feasibility through post-market, remote work with US-based location.