Manager, Regulatory Operations - Regulatory Data Management (Devices)

Alcon; Lake Forest (CA); On-site; USD 119,000 - 154,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

PTO for hourly associates

Job summary

Alcon seeks a Manager, Regulatory Operations (Management Path) to drive a controlled documentation system and coordinate global regulatory submission projects. You will guide teams in dossier preparation, submission publishing, licensing, and labeling across medical devices and pharmaceuticals.

The role is part of Alcon's Quality & Regulatory Affairs and requires leadership, project management, and regulatory expertise across US, EU, and Canada platforms.

Qualifications

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

Responsibilities

• 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

Skills

Regulatory operations

Project management

Cross-functional leadership

GxP/compliance

Education

Bachelor's degree or equivalent

Tools

FDA eSTAR

Health Canada REP

EU submission portals

Job description

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. Are you ready to join us?

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.

In this role, a typical day will include:

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

Alcon Careers

See your impact at alcon.com.careers

Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay, with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and wellbeing, provide financial security, and support retirement planning.

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

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