Labeling Technician

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 109,000 colleagues serve people in more than 160 countries.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Temecula, CA, currently has an opportunity for a Principal Labeling Specialist 

Will be responsible for the development of Medical Device product labeling for the division by coordinating across all functions and US and international sites. Maintains the division’s labeling documents and the labeling process to ensure compliance with all division policies as well as internal and external regulations. Interfaces with key functional areas such as Research & Development, Technical Product Support, Regulatory, QA, Purchasing, Packaging Engineering, etc.

WHAT YOU’LL DO

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Identify and inform project teams whether new labeling is required and/or whether existing labeling is impacted by the project and monitor project development.

• May join project teams in progress if labeling was not previously identified or the project scope has changed such that labeling is impacted.

• Coordinates with the project teams the labeling requirements and ensures that labeling requirements and processing timelines are completed to meet project deadlines.

• Works with the business to identify overall priorities and production strategies. Consistently identifies and implements labeling process improvement projects and creates and manages change requests within the document control system.

• Author/revise labeling process SOP(s) to meet the Division’s needs; Creates and modifies labeling for product labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devicesfollowing the established design format and branding guidelines; Complies with U.S. Food and Drug Administration (FDA) regulations, other global regulatory requirements, company policies, operating procedures, processes, and task assignments.

• Work with Regulatory Affairs to monitor and understand impact of changing regulations worldwide regarding labeling and stays up-to-date; assessing impact and developing plans for compliance when needed. Also maintains knowledge of new developments in packaging and labeling technologies and regulations.

• Guide the development of and implementation of training and tools to support the Label Process and build label process compliance/understanding across the Division.

• Ensures consistency with labeling material and that the project requirements are met.

• Communication of labeling projects and priorities across the division. Manages multiple concurrent deadlines. Employs project management skills to ensure multiple programs impacting labeling are progressing and meeting expected milestones.

• Strong organizational and human relations skills.  Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Strong written and oral communication skills and ability to present to management and to extended teams.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelors Degree in Graphic Arts, Science, Engineering, Business or related field
• Minimum 4 years working with product labeling within a quality system, and/or regulatory labeling.
• Knowledge of regulations and standards affecting Medical device products.
• Experience utilizing computer-aided design equipment and/or graphic tools (such as CAD, Adobe InDesign/Illustrator/Photoshop or other related software). Knowledge of XML language and coding a plus.
• Multi-tasks, prioritizes, and meets deadlines in timely manner
• Supervisory experience; strong leadership skills, follow-up skills and ability to hold others accountable
• Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority

• Production areas that are clean, well-lit and temperature-controlled

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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