Regulatory Affairs Associate

Regulatory Affairs Associate

Alcon

Warsaw, Poland

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 You’ll 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