Regulatory Affairs Manager I

Overview 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. Responsibilities Responsible for Lifecycle Management projects on lasers, accessories, and microscopes. Change Assessments and associated work, including advertising and promotion review. Manage individual projects within the Regulatory Affairs Strategy team to enhance project performance and operational efficiency. Coordinate product submissions, renewals, and updates by communicating with plants, agents, and authorities. Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with laws and regulations. Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage. Support medical device and pharmaceutical products, ensuring adherence to relevant regulations. Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed). Support post-market inspection and explain approved information to customers. Maintain approval information in internal systems. Focus on talent development to enhance capabilities and lead and mentor a team of professionals in Switzerland, driving operational efficiency and high performance. Qualifications Bachelor’s Degree or Equivalent. Years of directly related experience: 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. Location & Travel Location: Onsite, Lake Forest, CA. Travel Requirements: 0 – 10%. Relocation Assistance: Not Available. Sponsorship Available: Not Available. Compensation Pay Range: 130,900.00 – 169,400.00; Pay Frequency: Annual. Benefits Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more. Equal Opportunity Employer Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to View email address on click.appcast.io and let us know the nature of your request and your contact information. #J-18808-Ljbffr Alcon MX