GRA Labeling Manager

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 Lifecycle Management Specialist you will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices and pharmaceutical products. This role is essential in ensuring that all labeling activities comply with international regulations and standards, while effectively managing labeling content and artwork approvals. The position is responsible for advancing regulatory labeling practices, enhancing labeling processes, and integrating technology to streamline future operations at the Fort Worth (Main Facility), TX, USA

In this role, a typical day will include:

• Regulatory Labeling Compliance: Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, Health Canada and ISO.

• Content and Artwork Management: Oversee the management, review, and approval of Medical Device Labeling Content and artwork for various products, ensuring regulatory and internal compliance.

• Regulatory Objectives Support: Support regulatory objectives such as Post-Production Risk Reviews (PPRR), Risk Management Report (RMR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation.

• Regulatory Harmonization: Manage and implement harmonization activities to ensure consistent labeling across different markets and handle variations in response to unique local/regional requirements and regulatory changes.

• Technology Integration: Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.

• Continuous Improvement: Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.

• Expertise and Training: Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Biomedical engineering, etc.) or Equivalent years of directly related experience (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
• Work hours: 40hours
• Travel Requirements: 10% or less
• Relocation assistance: no
• Sponsorship available: no

Nice to Have (Preferred experience, skills, and abilities):

• Deep understanding of global medical device regulations including: FDA21 CFR part 801, European MDR/IVDR, and other labeling standards
• Familiarity with ISO standards related to labeling such as ISO 20417, ISO 15223-1, and ISO 13485
• Knowledge of labeling requirements across major markets including, US, EU, and Canada
• Ability to think strategically, navigate ambiguity, and decision-making

HOW YOU CAN THRIVE AT ALCON:

Collaborate with teammates to share standard processes and findings as work evolves.

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 a 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.