Packaging & Labeling Specialist I

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Labeling Specialist is responsible for the development of medical device labeling for the Division by coordinating across
functions as well as multiple US and international sites.

What You’ll Work On

• Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.
• Supports a cross-functional team collecting labeling content and translating it into functional label layouts utilizing labeling software.
• Mostly works on commercialized product labels.
• Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
• Creates and manages labeling change requests within the document management system.
• Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing and production techniques.
• Schedule/deadline provided for assigned work/tasks.
• Maintains knowledge of new developments in packaging and labeling technologies.
• Manages multiple concurrent deadlines.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),
• Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's Degree (± 16 years) or an equivalent combination of education and work experience
• Minimum 1 year working with product labeling, design dossiers, quality systems and/or regulatory labeling preferred.
• Required experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in an electronic environment.
• Experience utilizing computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop and other related software
• Ability to schedule and organize multiple projects.
• Ability to communicate effectively with internal and external customers and team members.
• Thorough knowledge of FDA, GMP, and ISO guidelines.
• Requires ability to be innovat