Manager I, Regulatory Affairs Strategy

Job Overview Manager I, Regulatory Affairs Strategy at Alcon supports regulatory compliance and strategy activities for Intraocular Devices, including intraocular lenses, implantable glaucoma devices and associated delivery systems. The position is based in Fort Worth, Texas (other on‑site locations available) and plays a key role in enabling compliant, timely access to innovative devices across global markets. Responsibilities Conduct specialized tasks and 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. Ensure rapid and ongoing approval of products and 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 (GDP) 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 industry association activities such as those of the Advanced Medical Technology Association (Advamed). Commit to continuous improvement in operations and contribute to the organization’s overall compliance. Maintain compliance with GxP regulations, SOPs, documentation and training requirements. Key Success Factors Ability to translate technical and clinical data into regulatory strategy. Strong collaboration and influence within a matrixed organization. Effective communication and regulatory writing skills. Ability to manage multiple priorities and timelines. Proactive problem‑solving and risk mitigation approach. Commitment to quality, compliance and patient safety. Qualifications Bachelor’s Degree or equivalent years of directly related experience (equivalency: High school +13 yrs; Associate +9 yrs; M.S. +2 yrs; Ph.D. +0 yrs). Proficient reading, writing and communication in English. Minimum 5 years of relevant experience. Benefits Health, life, retirement and flexible time‑off packages. Travel up to 10% of the assignment. Salary Pay Range: $119,000.00 – $154,000.00 (annual). EEO Statement 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 accommodations 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 to perform the essential functions of the position, please email View email address on click.appcast.io. #J-18808-Ljbffr