Director, Regulatory Affairs Operations
Core
Direct product/process registration submissions and provide strategic product direction for the medical device portfolio across Surgical and Vision Care Franchises.
Role type
Director, Regulatory Operations (Management Path)
Builds
Regulatory dossiers, marketing applications, and compliant product registrations for global markets.
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory submission management, dossier preparation, clinical trial disclosure, licensing, labeling, Veeva RIM Suite administration, SOP development, cross-functional team leadership, GxP compliance, strategic planning.
Preferred skills
None stated.
Technologies
Veeva RIM Suite
Responsibilities
Lead and mentor teams in dossier preparation, submission management, and publishing; maintain and drive continuous improvement for Veeva RIM Suite; create job aids for document approval processes; foster relationships with regulatory agencies and cross-functional teams; ensure timely and accurate submission of regulatory documents; adhere to GxP regulations and maintain rigorous quality control.
Seniority
Director, Management Path