Regulatory Affairs Associate

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 Global 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 Regulatory Affairs Associate is primarily responsible for implementing strategies to secure and maintain product approvals collaborating with teams support submission preparation managing lifecycles and ensuring regulatory compliance.

In this role a typical day will include:

• Support and/or prepare device regulatory filings for the worldwide registration of the Medical Devices developed at Alcon Grieshaber (CH) and Wavelight (DE).
• Assist in preparing and submitting specific regulatory documents ensuring compliance with relevant regulations
• Support answer preparation to regulatory requests from across the organization in a timely manner
• Develop documents that are clear concise and complete to facilitate reviews/approvals
• Ensure timely clear communications to internal stakeholders on project status and issues
• Maintain regulatory data in dedicated Alcon Systems and approval overview lists for all existing devices and their changes
• Verify available registration data to facilitate RPA approvals
• Follow established procedures with some decision-making authority within assigned tasks
• Demonstrate advanced attention to detail strong communication and familiarity with regulatory guidelines and processes
• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation and ensuring rigorous quality control
• Complete all required training and contribute to the overall compliance of the organization committing to continuous improvement in operations

WHAT YOULL BRING TO ALCON:

• Knowledge of Regulatory Affairs principles and processes including regulatory documentation preparation and submission
• Ideally at least 2 years of experience in Regulatory Affairs; recent graduates with relevant education and a strong interest in the field are also encouraged to apply
• University degree in Life Sciences or a related technical field
• Very good command of English both written and spoken
• Action-oriented results-driven mindset with strong sense of urgency
• Excellent communication and collaboration skills
• Solid planning organization and ability to manage multiple tasks

HOW YOU CAN THRIVE AT ALCON:

• Opportunity to work in a best-in-class organization in Medical Devices/Equipment sector
• Opportunity to work in a high-paced agile environment
• Truly international environment and daily interactions with colleagues from all over the world
• Work with people who are passionate about delivering strong outcomes and who embrace a culture of simplification and ownership.
• Possibility to influence the design of the solution responding to business needs to enhance customer experience
• Collaboration and frequent direct interactions with business stakeholders

• Truly international environment and daily interactions with colleagues from all over the world
• Attractive benefits package
• Permanent employment contract attractive base salary and annual bonus
• Flexible hours and hybrid work model
• Brand new office in Marynarska 15 Warsaw with a lot of facilities inside

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