Senior Manager, Regulatory Operations – Publishing & Registration (Devices)

About the role

Alcon is seeking a Senior Manager to lead regulatory operations for medical device and pharmaceutical products. The role focuses on overseeing submissions, publishing, licensing, and labeling to ensure timely approvals and compliance with global regulations.

Key responsibilities

• Oversee multiple regulatory operations projects, ensuring goals are met.
• Lead teams responsible for dossier preparation, clinical trial disclosure, submission management, publishing, licensing, and labeling.
• Make critical decisions that impact project performance and success.
• Apply project‑management, problem‑solving, and industry‑specific knowledge to drive results.
• Maintain compliance with GxP regulations, SOPs, and quality‑control standards.
• Promote continuous improvement and adherence to regulatory requirements.

Required profile

• Bachelor’s degree or equivalent experience (e.g., high school + 15 years, associate + 11 years, M.S. + 4 years, PhD + 3 years).
• Fluent English reading, writing, and communication skills.
• Minimum 7 years of relevant regulatory experience.
• At least 5 years of demonstrated leadership.
• On‑site availability in Fort Worth, TX (or Lake Forest, CA).
• First‑shift schedule, Monday‑Friday, with 0‑10 % travel.

Required skills

• Deep expertise in the regulatory submission lifecycle for Class I, II, III medical devices (US, EU, Canada).
• Proficiency with FDA eSTAR, Health Canada REP, and EU Notified Body submission portals.
• Experience managing export certification activities.

What we offer

• Opportunity to work within Alcon’s global Quality & Regulatory Affairs function.
• Inclusive culture with career growth and development programs.