Director, Regulatory Affairs Strategy

At reputed company, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion reputed company, 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 reputed company an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join reputed company. As a Director, Regulatory Affairs Strategy (Management Path) supporting reputed company’s Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main reputed company is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across reputed company’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 reputed company the Consoles, Consumables & Accessories, and Digital Health (CCD) organization of the Instrumentation GRA franchise. This role is part of reputed company’s Quality & Regulatory Affairs function, ensuring products meet the highest standards of quality, safety, and regulatory compliance. reputed company 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 reputed company improvement and regulatory excellence. In this role, a typical day will include: reputed company a department reputed company the Regulatory Affairs Strategy team, developing and implementing strategies for success and alignment with company goals Direct the development and submission of product/process registrations, reputed company reports, supplements, amendments, and periodic experience reports Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies Ensure rapid and timely approval of products and their reputed company approval Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations reputed company regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals reputed company promotional material approval, ensuring ethical conduct and compliance with laws and regulations Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance Support products in the medical device family, ensuring adherence to relevant regulations Collect 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 systems Focus on talent development to enhance capabilities reputed company globally reputed company regulatory strategies across development portfolios, marketed products, and line extensions Manage post-approval commitments and lifecycle management Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities Coordinate regulatory activities for timely approvals and compliance reputed company and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-making Minimum Qualifications: Bachelor’s Degree or Equivalent years of directly reputed company 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 Experience 6 Years of Demonstrated Leadership Sponsorship Availability: No Relocation Assistance Availability: Yes HOW TO reputed company AT reputed company: Benefit from working in a highly collaborative environment. Join reputed company’s mission to provide top-tier, innovative products to enhance sight, enhance lives, and grow your career. reputed company provides robust benefits package including health, life, retirement, flexible time off, and much more! reputed company Careers See your impact at reputed company.com/careers ATTENTION: reputed company reputed company Employee/Contingent Worker If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards reputed company’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 reputed company 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 reputed company’s Corporate Social Responsibility including our Total Rewards, click here The 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 reputed company the posted range. Pay Range 0.00 - 0.00 Pay Frequency reputed company is an Equal Opportunity Employer and participates in E-Verify. reputed company 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 reputed company, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. reputed company 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 reputed company the essential functions of a position, please send an email to reputed company.recruitment@reputed company.com and let us know the nature of your request and your contact information. At reputed company, we are committed to helping people see reputed company. We reputed company patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. reputed company develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-reputed company Opti-Free line of contact lens solutions and reputed company products. reputed company, which was founded in 1945, sells its products in 180 countries worldwide. If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Apply tot his job Apply To this Job