Senior Labeling Specialist

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 .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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

The Senior Labeling Specialist position works out of our Sylmar, CA location in the Cardiac Rhythm Management Division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Senior Labeling Specialist designs, creates, updates, and maintains labeling text, graphics, and specifications for new and existing medical device products. Coordinates with Engineering, Marketing, Clinical Research, and Regulatory Affairs to define product labeling requirements. Designs and updates labels/labeling to ensure accuracy, visual appeal, cost efficiency, and compliance with applicable regulations, industry standards, and company requirements.

 

MAIN RESPONSIBILITIES

What You'll Work On

 

This position:

• Gathers input for labels and IFUs from Engineering (Manufacturing, Packaging, etc.), Marketing, Clinical Research, and Regulatory Affairs (RA) to define specific requirements for product labeling by attending project meetings and meeting with or talking to individual content experts as necessary.

• Works with Engineering and RA to establish and maintain accurate marketing and geographical labeling build configurations by reviewing Marketing requirements and launch plans and RA filing strategies.

• Enhances professional appearance and legibility of Instructions for Use (IFU) by editing for grammar, consistency, style, and format.

• Assists with Regulatory submissions and filings by providing the relevant labeling samples and change information.

• Coordinates final labeling implementation to ensure that all requirements and deadlines are met by working with contract graphic designers, Abbott Vascular packaging experts, and print vendors.

• Produces labeling artwork by defining artwork requirements, designing formats using departmental computer graphics software (e.g., Adobe Photoshop, Adobe Illustrator, Adobe InDesign, MS Word, and EasyLabel), Label Vision Inspection System, or working with contract graphic designers, and creating artwork packages.. Prepares Change Orders (COs) and specifications for approval by writing CO and specifications for CO originator to obtain approvals.

• Maintains labeling history files and old versions of labels and IFUs by retaining samples of and documentation for the most current versions of artwork and archiving samples or electronic copies of previous labeling.

• Maintains internal procedures for labeling design, processing, and control to ensure compliance to legal requirements by regularly reviewing and updating the procedures as necessary.

• Monitors, evaluates, and recommends improvements to labeling processes, quality, systems, tools, and policies by staying informed of new technology, standards, regu