Regulatory Operations Leader - Data Management (Devices)

Alcon; Fort Worth (TX); On-site; USD 119,000 - 154,000; Full time

Benefits offered by this job

Benefits package

Job summary

Alcon in Fort Worth, TX is seeking a Manager, Regulatory Operations to lead document control, record retention, and global submissions within the Quality & Regulatory Affairs function. You will guide teams, maintain regulatory systems, and coordinate cross‑functional submission projects.

The role requires a Bachelor's degree or equivalent, 5+ years of relevant regulatory experience, and 3+ years of demonstrated leadership, with expertise across FDA eSTAR, Health Canada REP, and EU submission

Qualifications

• Bachelor's degree or equivalent years of directly related experience
• English proficiency: read/write/speak fluently
• 5+ years of relevant regulatory experience
• 3+ years of demonstrated leadership

Responsibilities

• Oversee regulatory operations projects and ensure goals are met
• Lead dossier preparation, submission management, and labeling
• Ensure compliance with GxP and SOPs
• Guide teams and manage cross‑functional submission timelines
• Apply project management and effective communication
• Maintain documentation systems and data quality

Skills

Project management

Leadership

Regulatory submissions

GxP knowledge

Education

Bachelor's degree or equivalent

Tools

FDA eSTAR

Health Canada REP

EU submission portals

Job description

Alcon in Fort Worth, TX is seeking a Manager, Regulatory Operations to lead document control, record retention, and global submissions within the Quality & Regulatory Affairs function. You will guide teams, maintain regulatory systems, and coordinate cross‑functional submission projects.

The role requires a Bachelor's degree or equivalent, 5+ years of relevant regulatory experience, and 3+ years of demonstrated leadership, with expertise across FDA eSTAR, Health Canada REP, and EU submission