Manager I, Regulatory Affairs Strategy - Global

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.

At Alcon, the Manager I, Regulatory Affairs Strategy - Global is responsible for the regulatory lifecycle management aspects of products out of the Lake Forest and Fort Worth design centers, including: change analyses, submissions, project team support, and any other necessary duties.

Product Regulatory Affairs (Life Sciences & Agriculture) work includes:

• Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports
• Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies
• Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions *
• Serving as a regulatory liaison on the project team throughout the product lifecycle
• Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan,
• Ensuring pre-clinical and clinical trial designs meet regulatory requirements
• Ensuring rapid and timely approval of medical devices and continued approved status of medical devices
• Serving as regulatory representative to marketing or research project teams and government regulatory agencies
• Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
• Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for medical devices and marketed products notices.

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+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience

Preferred Experience:

• Regulatory Experience with Medical Devices

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon's 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 robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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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.