Manager, Regulatory Operations - Regulatory Data Management (Devices)

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

• 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, * 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

• 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!, 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

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?