• Principle Labeling Specialist

    AbbottDes Plaines, IL 60019

    Job #1205117199

  • 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 103,000 colleagues serve people in more than 160 countries.Principle Labeling SpecialistAt Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve._At Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics._Position Summary:Will be responsible for the development of Medical Device/ In Vitro Diagnostic product labeling for the division by coordinating across all functions and US and international sites. They are responsible for their staff's performance with respect to quality, delivery, and cost.Responsibilities:+ Responsible for implementing and maintaining the effectiveness of the quality system.+ Oversee and manage the AMD Labeling processes, systems, and communications with internal and external business partners. 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 devices/in vitro diagnostic devices (IVDs) following 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 insure 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.+ Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.Education/ Skills/ Experience:+ Bachelors Degree - Graphic Arts, Science, Engineering, Business or related field .+ Four Plus years experience working with product labeling within a quality system, and/or regulatory labeling.+ Knowledge of regulations and standards affecting Medical device/In Vitro Diagnostic (IVD) 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?An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our ~~~ provide reasonable accommodation to qualified individuals with ~~~ request accommodation, please call ~~~ or email ~~~

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