Senior Associate I, Regulatory Affairs Strategy

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. We foster an inclusive culture and are looking for diverse, dedicated people to join Alcon. As a Senior Associate I, Regulatory Strategy joining our Regulatory Affairs team in Lake Forest, CA, you are responsible for providing support in ensuring compliance with all FDA and other U.S. and global regulatory requirements. This position supports internal and global customers to meet corporate submission and registration objectives for timely approval.

• Work with global partners and support worldwide registrations efforts.
• Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives.
• Manages requests from regions and countries, provides responses and requested documentation (CFG's, FSC, certifications, Letter of Authorization, etc.) in a timely manner.
• Prepares supporting documentation and arrange for legalizations, as required by country regulations.
• Support communications with US and international affiliates and regulatory personnel.
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
• Provides high quality regulatory support for assigned products/projects.
• Develops documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses.
• Prepare, consolidate, response and follow-up on change assessments for global regulatory strategies.
• Review and approve labeling to ensure accuracy of content.
• Maintain a current knowledge of global medical device regulations pertaining to the distribution of products, which include facility registration and device listing.
• Maintain documentation and a historical record for regulatory submissions.
• Notarize regulatory registration documents as necessary. Willing to obtain notary license in California.

WHAT YOU'LL BRING TO ALCON:

Key Requirements/Minimum Qualifications:

• Bachelor's 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

How you can thrive at Alcon:

• Benefit from working in a highly collaborative environment.
• 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!
• Travel Requirements: 10%
• Relocation assistance: No
• Sponsorship available: No

ATTENTION: Current Alcon Employee/Contingent Worker

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Total Rewards

Alcon's Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon's Corporate Social Responsibility including our Total Rewards, click here

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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.