Regulatory Affairs Manager I

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD1 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 Alcons 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 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

Alcons Total Rewards programs are designed to align incentives with business objectives support our values and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay with shortterm and longterm 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 wellbeing 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

Pay Frequency

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 and let us know the nature of your request and your contact information.