Director, Regulatory Affairs Strategy

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Director, Regulatory Affairs Strategy (Management Path) supporting Alcon’s Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios. This position plays a critical role in ensuring products and processes meet global, regional, and local regulatory requirements.Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals. Additional responsibilities include leading and developing regulatory teams, collaborating cross‑functionally with R&D, Quality, Manufacturing, and Commercial partners, and driving lifecycle management strategies to ensure ongoing compliance and business continuity.The Director will be responsible for the Consoles sub-team within the Consoles, Consumables & Accessories, and Digital Health (CCD) organization of the Instrumentation GRA franchise.This role is part of Alcon’s Quality & Regulatory Affairs function, ensuring products meet the highest standards of quality, safety, and regulatory compliance. All associates are required to adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, completing required training, and supporting a culture of continuous improvement and regulatory excellence.In this role, a typical day will include: Lead a department within the Regulatory Affairs Strategy team, developing and implementing strategies for success and alignment with company goalsDirect the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reportsProvide strategic product direction to teams and negotiate evidence requirements with regulatory agenciesEnsure rapid and timely approval of products and their continued approvalServe as the regulatory representative to marketing, research project teams, and government regulatory agenciesAdvise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulationsOversee regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvalsOversee promotional material approval, ensuring ethical conduct and compliance with laws and regulationsProvide regulatory strategies for new product introductions and product changes, maintaining regulatory complianceSupport products in the medical device family, ensuring adherence to relevant regulationsCollect and analyze regulations/standards to ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association (AdvaMed)Support post-market inspection and explain approved information to customers, maintaining approval information in internal systemsFocus on talent development to enhance capabilitiesLead globally aligned regulatory strategies across development portfolios, marketed products, and line extensionsManage post-approval commitments and lifecycle managementGuide teams on product development, safety, efficacy, and compliance while interacting with health authoritiesCoordinate regulatory activities for timely approvals and complianceLead and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-makingMinimum Qualifications: Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs.; Assoc.+14 yrs.; M.S.+7 yrs.; PhD+6 yrs.)The ability to fluently read, write, understand, and communicate in English.10 Years of Relevant Experience6 Years of Demonstrated LeadershipSponsorship Availability: No Relocation Assistance Availability: YesHOW TO THRIVE AT ALCON: Benefit from working in a highly collaborative environment.Join Alcon’s mission to provide top-tier, innovative products to enhance sight, enhance lives, and grow your career.Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!Alcon Careers See your impact at alcon.com/careersATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.Find Jobs for EmployeesFind Jobs for Contingent WorkerTotal RewardsAlcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click hereThe salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.Pay Range0.00 - 0.00Pay FrequencyAlcon 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.SummaryLocation: Lake Forest, California; Fort Worth, TexasType: Full time