Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)

Role: Senior Manager, Regulatory Operations within Alcon's Quality & Regulatory Affairs, leading product/process submissions for medical devices and pharmaceuticals. Responsibilities: oversee multiple regulatory projects, manage dossier creation, clinical trial disclosures, submission processes, and licensing; lead negotiations for regulatory strategies; ensure compliance with GxP, SOPs, and quality standards; drive continuous improvement. Requirements: Bachelor's degree (or equivalent experience), 7+ years in regulatory operations, 5+ years of leadership; proficient in regulatory submission lifecycle across Class I-III medical devices in US, EU, Canada; knowledge of electronic submission platforms (FDA eSTAR, Health Canada REP, EU portals); experience with export certification systems. Preferred: deep expertise in global registration pathways, process optimization, and international documentation. High-Value: medical devices (Class I-III), global regulatory submissions, US/EU/Canada markets, international documentation processes. WorkSetup: onsite in Fort Worth, TX or Lake Forest, CA; travel 0-10%; schedule: Monday-Friday, first shift.