Manager, Regulatory Operations Regulatory Data Management (Devices)

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD1 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 Alcons 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!

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Compensation and Benefits

Alcons 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.

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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 and let us know the nature of your request and your contact information.