Sr. Manager, GRA Labeling

Alcon Research • Fort Worth, TX

16d • Onsite

About The Position

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. The Sr. Manager, GRA Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for Surgical Medical Device 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. As a Sr. Manager, GRA Labeling supporting the Global Regulatory Affairs Team in Houston or Fort Worth, TX, Irvine or Lake Forest, CA, Sinking Springs, PA 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. Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations. Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge. Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training. Meet individual job requirements and contribute to the overall compliance of the organization.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training.

Responsibilities

• Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, Health Canada and ISO.
• Oversee the management, review, and approval of Medical Device Labeling Content and artwork for various products, ensuring regulatory and internal compliance.
• 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.
• 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.
• Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.
• Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.
• Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes.
• Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations.
• Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge.
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training.
• Meet individual job requirements and contribute to the overall compliance of the organization.

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees