Manager II, Regulatory Affairs Strategy

Overview 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. At Alcon, you'll be recognized for your contributions, supported by an inclusive culture, and empowered 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. Are you ready to join us? Role Summary This role is part of Alcon's Quality & Regulatory Affairs function—a critical organization responsible for ensuring our products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality. As a Manager II, Regulatory Affairs Strategy , you will support regulatory compliance activities for Alcon's Surgical portfolio , including consumable and accessory medical devices. This onsite position is based in Houston, Texas (other onsite locations available) and plays an important role in enabling compliant and timely product access across the global marketplace. Typical Day / 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 timely submissions and approvals. Oversee promotional material approval, ensuring ethical conduct and compliance with laws, codes, and regulations. Ensure rapid and timely approval of products and their continued approval. 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. Collect and analyze regulations and standards to ensure product compliance, and engage in activities of industry associations such as Advanced Medical Technology Association (AdvaMed) as needed. Commit to continuous improvement in operations and contribute to the organization's overall compliance. Key Requirements / Minimum Qualifications Bachelor's Degree or equivalent years of directly related experience (or high school + 13 yrs. Assoc.+9 yrs.; M.S.+2 yrs.; PhD+0 yrs.) Fluent reading, writing, understanding, and communication in English. At least 5 years of relevant experience in medical device regulatory affairs. Relocation assistance: Not available. Sponsorship: Not available. Benefits Manage your own workload and schedule while hitting your set targets. Build positive working relationships to achieve business objectives. Robust benefits package including health, life, retirement, and flexible time off for exempt associates. Compensation Pay Range : $119,000.00 – $154,000.00 per year. Equal Employment Opportunity 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