Overview

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.

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.

Role Summary

The Associate II, Regulatory Operations is primarily responsible for applying specialized knowledge to support project goals through regulatory submissions, database maintenance, and compliance with external regulations.

Responsibilities

• •Handle complex tasks related to regulatory operations, ensuring timely and accurate submission of regulatory documents
• •Maintain up-to-date databases of submissions and approvals
• •Prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing, and labeling
• •Maintain Regulatory Affairs Archives and Tech File Administration
• •Follow procedures with decision-making authority, requiring job-related training and attention to detail
• •Ensure products comply with external regulations, internal standards, and customer requirements
• •File product notifications, approval applications, and quality testing results with government and regulatory agencies
• •Interpret proposed regulations and advise management on their impact
• •Implement and audit compliance processes
• •Provide guidance to development and marketing teams on product changes, quality testing, labeling, literature, and advertising
• •Adhere to GxP regulations by following Standard Operating Procedures (SOPs) and maintaining accurate documentation
• •Ensure rigorous quality control, complete all required training, and commit to continuous improvement in operations

Preferred Qualifications

• •Familiarity with Unique Device Identification (UDI) requirements and data management processes across global markets, such as GUDID and EUDAMED
• •Demonstrated organizational and time management skills, with the ability to prioritize multiple projects and consistently meet deadlines
• •Strong communication and interpersonal skills, with the ability to proactively identify issues, manage risks, resolve conflicts, and drive solutions
• •Ability to work effectively in a cross-functional, matrixed environment and influence stakeholders to achieve business objectives
• •Strong attention to detail and commitment to delivering high-quality results in a fast-paced environment
• •Ability to adapt to changing priorities while maintaining focus on key deliverables and timelines
• •Knowledge of regulatory information management (RIM) systems and regulatory data governance principles