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Senior Associate I, Regulatory Affairs Strategy

Alcon
flex time
United States, Texas, Fort Worth
6201 South Freeway (Show on map)
Apr 10, 2025

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, 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 make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Associate I, Regulatory Affairs Strategy you will be responsible for the implementation and maintenance of the defined medical device regulatory strategy, under limited supervision.

In this role, a typical day will include:

  • Manage and/or prepare device regulatory filings with a thorough understanding of the US FDA and EU (MDD/MDR) regulatory requirements.

  • Review and access process and/or design change controls for potential impact on current medical device regulatory filings.

  • Provides high quality regulatory support for assigned products/projects.

  • Works in close collaboration with internal stakeholders and supports multiple projects.

  • Provides support as needed for non-project related "regulatory excellence" activities.

  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes.

  • Responds to regulatory requests from across the organization in a timely manner.

  • Partners with internal stakeholders (e.g., regions) to align on regulatory strategy to achieve business objectives.

  • Develops training programs for internal stakeholders, as needed.

  • Develops documents that are clear, concise, and complete to facilitate reviews/approvals.

WHAT YOU'LL BRING TO ALCON:

  • Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6yrs; M.S.+0 yrs)

  • The ability to fluently read, write, understand, and communicate in English.

PREFERRED QUALIFICATIONS:

  • 2 Years of Relevant Experience

  • 1 Year of demonstrated project leadership and or management

HOW YOU CAN THRIVE AT ALCON:

  • 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 and much more.

  • This role offers flexibility to operate from multiple Alcon locations across the United States.

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.

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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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

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