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

Role: Senior Manager, Regulatory Operations within Alcon's Quality & Regulatory Affairs, primarily overseeing global regulatory submissions for medical devices and pharmaceutical products. Responsibilities include directing dossier preparation, submission management, clinical trial disclosures, licensing, labeling, and ensuring compliance with GxP standards; leading cross-functional teams; optimizing regulatory processes; and maintaining high-quality documentation. Requirements: Bachelor's degree or equivalent with 7+ years of relevant regulatory experience, including at least 5 years in leadership. High-value biopharma specifics: expertise in U.S., EU, and Canadian regulatory pathways for Class I-III medical devices; familiarity with FDA eSTAR, Health Canada REP, EU Notified Body portals, and export certification systems; experience in international registration strategies and process optimization. Location: Onsite in Fort Worth, TX, or Lake Forest, CA; travel 0-10%. Preferred skills include deep knowledge of global submission lifecycle, regulatory platforms, and process improvement practices. The role emphasizes leadership, strategic guidance, regulatory compliance, and operational efficiency in a regulated medical device and pharmaceutical environment.