Sr. Associate II, Regulatory Affairs Strategy

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates worldwide we innovate fearlessly champion progress and act with speed to advance global eye health. At Alcon youll be recognized for your contributions supported by an inclusive culture and empowered to grow your career like never before. Together we go above and beyond to make a meaningful 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 critical organization responsible for ensuring our products comply with global local and internal regulatory requirements while meeting the highest standards of quality as we help people see brilliantly. The Sr. Associate II Regulatory Affairs Strategy is primarily responsible for supporting regulatory compliance activities for Alcons Surgical portfolio. This onsite position is based in Lake Forest California and plays an important role in enabling compliant and timely product access across the global marketplace.

In this role you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. You will support regulatory strategy execution with a focus on Retina medical devices within the Surgical franchise partnering crossfunctionally to ensure alignment with evolving regulatory expectations. Through your work you will help strengthen regulatory excellence support business objectives and uphold Alcons commitment to quality compliance and patient safety.

Specifics include:

• Perform specialized tasks and conduct 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 rapid and timely submissions and approvals.
• Develop product submission packages that are clear concise and complete to facilitate reviews/approvals.
• Oversee promotional material approval ensuring ethical conduct and compliance with laws codes and regulations.
• 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 (GxP) regulations by following Standard Operating Procedures (SOPs) maintaining documentation ensuring quality control and completing required training.
• Commit to continuous improvement in operations and contribute to the organizations overall compliance.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation and completing all required training.
• Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
• Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 10 yrs; Assoc.6 yrs; M.S.0 yrs)
• The ability to fluently read write understand and communicate in English
• 2 Years of Relevant Experience
• Location: Onsite
• Travel Requirements: 0-10%
• Relocation assistance: Not Available
• Sponsorship available: Not Available

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• Regulatory Affairs experience in medical devices or healthcare.
• Regulatory Affairs Certified (RAC).
• Knowledge of global regulations (FDA EU MDR ISO 13485) and GxP/quality systems.
• Experience with global regulatory submissions (e.g. US PMA US 510(k) EU CE Mark) and medical device lifecycle management.
• Ability to develop and execute regulatory strategies for new products and changes.
• Familiarity with ophthalmic/retina or surgical medical devices.
• Strong technical writing and submission documentation skills.
• Experience collaborating cross-functionally and with regulatory authorities.
• Strong analytical research and problem-solving abilities.
• Excellent communication organization and attention to detail.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides a 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

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

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.