Manager, Regulatory Operations - Regulatory Data Management (Devices)

Alcon MX; 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

About Alcon

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers.

Role Overview

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager, Regulatory Operations (Management Path) is primarily responsible for ensuring a controlled documentation system, record retention, and information services in line with regulatory requirements. You will guide and manage others to achieve goals, maintain documentation systems, and coordinate global regulatory submission projects.

Typical Day

• Oversee multiple regulatory operations projects, ensuring goals are met through effective management and oversight in support of medical device and/or pharmaceutical products
• Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling, ensuring timely and accurate submission of regulatory documents
• Make key decisions impacting project performance and success
• Apply project management, advanced problem‑solving, effective communication, leadership, and industry‑specific knowledge
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and ensuring quality control
• Commit to continuous improvement and compliance with regulatory requirements

What You'll Bring to Alcon

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr) The ability to fluently read, write, understand and communicate in English 5 Years of Relevant Experience 3 Years of Demonstrated Leadership

Location and Schedule

Location: Onsite- Fort Worth, TX, Lake Forest, CA Schedule: 1st Shift: Monday - Friday Travel Requirements: 0-10% Sponsorship & Relocation: Not Available

Preferred Qualifications/Skills/Experience

Manage a team, supervising day-to-day operations to ensure productivity and alignment with departmental objectives for medical devices. Demonstrates expertise in the regulatory submission lifecycle and associated processes for Class I, Class II, and Class III medical devices across the United States, European Union, and Canada Identify and implement process improvements that reduce submission cycle times, enhance compliance, and improve the quality and consistency of regulatory documentation Manage data entry, maintenance and registration hierarchy Demonstrated ability to develop and deliver clear, concise, and impactful presentations to executive leadership and senior stakeholders. Strong project management skills, with the ability to lead cross‑functional initiatives, manage competing priorities, and deliver results within established timelines. Excellent communication and stakeholder management skills, including the ability to influence and engage audiences at all organizational levels. Proven ability to organize, prioritize, and drive multiple projects simultaneously in a fast‑paced environment. Apply data quality & validation checks at point of collection Define KPIs – cycle time, first-pass yield, on‑time renewal Monitor and report performance metrics & trends over time Monitor dashboards & reports Automate data workflows & trackers (PowerApps / Power Automate Perform data reconciliation Possess comprehensive knowledge of key regulatory submission platforms and portals, including the U.S. Food and Drug Administration (FDA) electronic Submission Template and Resource (eSTAR), Health Canada Regulatory Enrolment Process (REP), and European Union Notified Body submission portals

How You Can Thrive At Alcon

Collaborate with teammates to share standard processes and learnings as work evolves! See your career like never before with focused growth and development opportunities! Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

Benefits

Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Compensation

Alcon’s Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long‑term value. Our compensation approach includes a combination of fixed and variable pay, with short‑term and long‑term incentive opportunities for eligible roles. The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range 119,000.00 - 154,000.00 Pay Frequency Annual

Equal Opportunity Employer

Alcon is an Equal Opportunity Employer and participates in E-Verify.

Diversity and Inclusion

Alcon takes pride in maintaining a diverse environment, and our policies are not to discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

Accommodation for Disabilities

Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

Mission Statement

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well‑known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.