CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Job Summary:

The Principal Labelling Specialist is responsible for the development and assessment of requirements for product labelling by coordinating across functions internationally and with CVI Operations sites. The Principal Labelling Specialist is responsible for the project pipeline as it relates to labelling requirements and changes and is responsible for prioritizing and deploying projects to meet compliance deadlines.

Essential Functions & Accountabilities:

• Review and comment on internal or external guidelines and regulations on safety, environmental and legal topics. Responsible for compilation of these requirements and assessing their impact against the CooperVision portfolio.
• Maintains knowledge of changes and new developments in packaging and labeling technologies and regulations.
• Coordinates with the project teams the labeling requirements and ensures that labeling requirements and processing timelines are completed to meet project deadlines.
• Supports the Global Packaging Director to identify overall priorities and communicate labelling strategies across the business.
• Consistently identifies and implements labeling process improvement projects and creates and initiates projects within the quality management system.
• Author/revise labeling policy documents to meet internal and external needs. Ensures that strategy meets all medical, legal, environmental, safety and regulatory requirements for medical devices following the established CooperVision branding guidelines.
• Works with cross functional teams to monitor and understand impact of changing regulations worldwide regarding labeling. Stays up to date with current landscape and assesses impact and develops plans with Project Management resources when required.

Travel Requirements:

5-10% domestic and international travel, as required

Qualifications

Knowledge, Skills and Abilities:

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Excellent interpersonal and written communication skills to present information and communicate effectively at all levels within the company as well as cross functionally with departments such as Regulatory, Quality, Purchasing, Operations and Marketing. Ability to present to management and to extended teams.
• Manages multiple concurrent deadlines. Employs project management skills to ensure multiple programs impacting labeling are progressing and meeting expected milestones.
• Ability to work in a team environment including multi-site cross-functional team members across geographies and time zones.
• Ability to read, analyze, and interpret professional journals, government regulations and standards, controlled documents, and procedures.
• Ability to enforce standards and standardize processes
• Strong computer skills working with Microsoft Office Suite and Visio
• Willing to flex work hours to meet the needs of a global organization.
• Anticipate and plan for changes within ongoing regulation changes.
• Able to build and maintain strong relationships necessary for influencing organizations outside of Global Packaging.

Work Environment:

• Normal office environment
• Sedentary to light physical effort necessary to perform the job

Experience:

• 5 years’ working with product labeling within a quality system, and/or regulatory labeling required, 10 years preferred.
• Knowledge of regulations and standards affecting medical device products.
• Project Management leadership experience with relation to technical and/or engineering programs.

Education:

• Bachelor’s degree required in Science, Engineering, Engineering Technology, or similar field.