Regulatory Operations Lead: Medical Device Submissions

Alcon; Fort Worth (TX); On-site; USD 152,000 - 197,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Flexible scheduling

Job summary

Alcon is seeking a Sr. Manager, Regulatory Operations to direct product and process submissions globally, ensuring timely approvals and high-quality regulatory support.

You will lead negotiations on optimized regulatory strategies and manage global submissions to enhance product value. The role demands deep regulatory expertise across US, EU, Canada, and international markets, strong leadership, and a track record of reducing cycle times while maintaining compliance.

Qualifications

• Experience with US FDA eSTAR and Health Canada REP.
• 7+ years of regulatory experience and 5+ years of leadership.
• Experience with Class I-III medical devices and global submissions.

Responsibilities

• Oversee regulatory operations projects ensuring goals are met.
• Lead teams for dossier prep, submission management, licensing, labeling.
• Make key decisions impacting project performance and success.
• Apply project management, problem solving, communication, leadership.
• Adhere to GxP regulations and SOPs; maintain documentation quality.
• Commit to continuous improvement and regulatory compliance.

Skills

Regulatory leadership

Project management

Regulatory strategy

Communication

GxP SOPs

Education

Bachelor's degree or equivalent

Tools

FDA eSTAR

CDRH CECATS

Health Canada REP

Job description

Alcon is seeking a Sr. Manager, Regulatory Operations to direct product and process submissions globally, ensuring timely approvals and high-quality regulatory support.

You will lead negotiations on optimized regulatory strategies and manage global submissions to enhance product value. The role demands deep regulatory expertise across US, EU, Canada, and international markets, strong leadership, and a track record of reducing cycle times while maintaining compliance.