Manager, Regulatory Operations - Regulatory Data Management (Devices)

Role: Manager, Regulatory Operations within Alcon's Quality & Regulatory Affairs, overseeing documentation, record retention, and global regulatory submission projects for medical devices. Responsibilities include managing teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, licensing, and labeling, ensuring compliance, timeliness, and quality. Requires 5+ years of relevant experience, 3+ years in leadership, and a Bachelor's degree or equivalent; familiarity with regulatory submission lifecycle for Class I-III medical devices across US, EU, and Canada is preferred. HighValue: Medical devices (Class I-III), global regulatory submissions, GxP compliance, team management, process improvement, knowledge of platforms like FDA eSTAR, Health Canada REP, and EU portals. Work setup: Onsite in Fort Worth, TX or Lake Forest, CA, with minimal travel (0-10%).