Skip to main content
Back to jobs

Regulatory Affairs Manager I

External
alcon logoAlcon · Lake Forest, CA
Full-timeOn-siteToday
ComplianceDocumentationLeadership
Cover LetterConnect

Prepare for this interview

Elite

AI-generated questions, company research, and talking points tailored to this role


Benefits

Health insurancePaid time offFlexible scheduleEquity / stock options

Additional Information

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. You will build effective relationships with plants, agents, and authorities to secure timely approvals and provide regulatory strategies for new products and changes. Occasionally, you will represent the Regulatory Affairs Senior Manager, when requested. In this role, a typical day will include: Responsible for Lifecycle Management projects on lasers, accessories, and microscopes. Change Assessments and associated work, including advertising and promotion review. Manage individual projects within the Regulatory Affairs Strategy team to enhance project performance and operational efficiency Coordinate product submissions, renewals, and updates by communicating with plants, agents, and authorities Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with laws and regulations Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage Support medical device and pharmaceutical products, 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 regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed) Support post-market inspection and explain approved information to customers Maintain approval information in internal systems Focus on talent development to enhance capabilities and lead and mentor a team of professionals in Switzerland, driving operational efficiency and high performance WHAT YOU'LL BRING TO ALCON: Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr) The ability to fluently read, write, understand and communicate in English 5 Years of Relevant Experience 3 Years of Demonstrated Leadership Location : Onsite, Lake Forest, CA Travel Requirements : 0 - 10% Relocation Assistance : Not Available Sponsorship Available : Not Available HOW YOU CAN THRIVE AT ALCON: Collaborate with teammates to share standard processes and learnings as work evolves! See your career like never before with focused growth and development opportunities Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more! Alcon Careers See your impact at alcon.com/careers ATTENTION: Current Alcon Employee/Contingent Worker If 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 Employees Find Jobs for Contingent Worker Compensation and Benefits Alcon's Total Rewards programs 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. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and well‑being, provide financial security, and support retirement planning. 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 outside the posted range. Pay Range 130,900.00 - 169,400.00 Pay Frequency Annual 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, trai


Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at alcon? Share your experience

Interested in this role?

Apply on the company's website.

Cover LetterConnect