Director, Regulatory Operations — Medical Devices (Fort Worth)

Alcon; Fort Worth (TX); On-site; USD 200,000 - 259,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Alcon is seeking a Director, Regulatory Operations (Management Path) to direct product and process registration submissions and provide strategic direction to teams. The role emphasizes leading multidisciplinary groups, building relationships with regulatory bodies, and driving SOP-driven compliance across global regulatory activities.

The position sits onsite in Fort Worth, TX, requires 10+ years in regulatory roles and 6+ years of leadership, and offers a competitive annual salary with a

Qualifications

• Bachelor's Degree or equivalent years of directly related experience.
• Fluently read, write, and communicate in English.
• 10+ years of relevant experience.
• 6+ years of demonstrated leadership.

Responsibilities

• Lead and mentor teams in dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling.
• Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and rollout to cross-functional teams.
• Create job aids detailing document approval processes, workflows, and submission tracking.
• Provide user requirements and recommendations for Veeva auto releases and configurations and update SOPs accordingly.
• Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions.
• Ensure timely and accurate submission of regulatory documents.

Skills

Leadership

Regulatory affairs leadership

Cross-functional collaboration

Submission management

GxP compliance

Education

Bachelor's Degree

Tools

Veeva RIM Suite

Job description

Alcon is seeking a Director, Regulatory Operations (Management Path) to direct product and process registration submissions and provide strategic direction to teams. The role emphasizes leading multidisciplinary groups, building relationships with regulatory bodies, and driving SOP-driven compliance across global regulatory activities.

The position sits onsite in Fort Worth, TX, requires 10+ years in regulatory roles and 6+ years of leadership, and offers a competitive annual salary with a