Sr. Associate II, Regulatory Affairs Strategy

At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. We recognise your contributions, support an inclusive culture, and empower you to grow your career like never before. Together, we go above and beyond to make a meaningful difference in the lives of our patients and customers. This role is part of Alcon’s Quality & Regulatory Affairs function, a critical organisation responsible for ensuring our products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality as we help people see brilliantly. The Sr. Associate II, Regulatory Affairs Strategy is primarily responsible for supporting regulatory compliance activities for Alcon’s Surgical portfolio. This onsite position is based in Lake Forest, California and plays an important role in enabling compliant and timely product access across the global marketplace. In this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. You will support regulatory strategy execution with a focus on Retina medical devices within the Surgical franchise , partnering cross-functionally to ensure alignment with evolving regulatory expectations. Through your work, you will help strengthen regulatory excellence, support business objectives, and uphold Alcon’s commitment to quality, compliance, and patient safety. Responsibilities Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals. Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure rapid and timely submissions and approvals. Develop product submission packages that are clear, concise, and complete to facilitate reviews and approvals. Oversee promotional material approval, ensuring ethical conduct and compliance with laws, codes, and regulations. Manage post‑approval commitments and lifecycle management. Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage. Support products in the medical device family, 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. Commit to continuous improvement in operations and contribute to the organisation’s overall compliance. All associates must adhere to GxP regulations by strictly following SOPs, maintaining accurate and complete documentation, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organisation. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations. What You’ll Bring to Alcon Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Associate +6 yrs; M.S. +0 yrs) The ability to fluently read, write, understand and communicate in English 2 Years of Relevant Experience Location: Onsite Travel Requirements: 0-10% Relocation assistance: Not Available Sponsorship available: Not Available Preferred Qualifications / Skills / Experience Regulatory Affairs experience in medical devices or healthcare. Regulatory Affairs Certified (RAC). Knowledge of global regulations (FDA, EU MDR, ISO 13485) and GxP/quality systems. Experience with global regulatory submissions (e.g., US PMA, US 510(k), EU CE Mark) and medical device lifecycle management. Ability to develop and execute regulatory strategies for new products and changes. Familiarity with ophthalmic/retina or surgical medical devices. Strong technical writing and submission documentation skills. Experience collaborating cross-functionally and with regulatory authorities. Strong analytical, research, and problem-solving abilities. Excellent communication, organisation, and attention to detail. How You Can Thrive at Alcon Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! Collaborate with teammates to share standard processes and findings as work evolves! See your career like never before with focused growth and development opportunities! Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more! Compensation and Benefits Alcon’s Total Rewards programmes are designed to align incentives with business objectives, support our values, and deliver long-term value. Our compensation approach includes a combination of fixed and variable pay, with short-term and long-term incentive opportunities for eligible roles. Pay Range 102,850.00 - 133,100.00 Pay Frequency Annual 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