Manager, Regulatory Operations - Regulatory Data Management (Devices)

Alcon•Fort Worth, TX

2d•$119,000 - $154,000•Onsite

About The Position

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.

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

Nice To Haves

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
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
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

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
Manage a team, supervising day-to-day operations to ensure productivity and alignment with departmental objectives for medical devices.
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
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