Manager, Regulatory Operations – Regulatory Data Management

About the role

Alcon is seeking a Manager of Regulatory Operations to lead documentation systems, record retention, and information services for medical device and pharmaceutical products. The role involves guiding teams, ensuring compliance with global regulations, and supporting regulatory submission projects.

Key responsibilities

• Oversee multiple regulatory operations projects, ensuring goals are met for medical device and pharmaceutical products.
• Lead teams responsible for dossier preparation, clinical trial disclosure, submission management, licensing, and labeling.
• Apply project management, problem‑solving, and leadership to make key decisions impacting project performance.
• Maintain compliance with GxP regulations, SOPs, and quality control standards.

Required profile

• Bachelor’s degree or equivalent experience with at least 5 years of relevant regulatory experience.
• Minimum 3 years of demonstrated leadership managing day‑to‑day operations.
• Fluent in English, both written and spoken.
• On‑site location in Fort Worth, TX with 0‑10% travel.

Required skills

• Expertise in regulatory submission lifecycle for Class I‑III medical devices (US, EU, Canada).
• Experience with FDA eSTAR, Health Canada REP, and EU Notified Body submission portals.
• Proficiency in PowerApps and Power Automate for automating data workflows.
• Data quality and validation checks, KPI definition (cycle time, first‑pass yield), and performance monitoring.