Manager I, Regulatory Affairs Strategy

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

Alcon is looking to hire a Manager I Regulatory Affairs Strategy Regulatory Affairs Strategy you will support regulatory compliance and strategy activities for Alcons Intraocular Device portfolio including intraocular lenses (IOLs) implantable glaucoma devices and associated delivery systems. This onsite position is based in Fort Worth Texas (other on-site locations available) and plays a key role in enabling compliant timely access to innovative devices across global markets.

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 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.

This role is on-site at any Alcon locations and a typical day would 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 timely submissions and approvals.
• Ensure rapid and timely approval of products and their continued approval.
• 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 (GDPs) regulations by following Standard Operating Procedures (SOPs) maintaining documentation ensuring quality control and completing required training.
• Support the collection and analysis ofregulations/standardsto ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association as needed (Advamed).
• 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.

Key Success Factors

• Ability to translate technical and clinical data into regulatory strategy
• Strong collaboration and influence skills within a matrixed organization.
• Effective communication and regulatory writing skills
• Ability to manage multiple priorities and timelines
• Proactive approach to problem-solving and risk mitigation
• Commitment to quality compliance and patient safety

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; PhD0 yrs)
• The ability to fluently read write understand and communicate in English
• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• 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 a robust benefits package including health life retirement flexible time off and much more.
• Travel up to 10%

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.