Associate II, Regulatory Operations

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 Associate II Regulatory Operations (Professional Path) is primarily responsible for applying specialized knowledge to support project goals through regulatory submissions database maintenance and compliance with external regulations. Specifics include:

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 Good Practice (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

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

• 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.