Product Labeling Specialist II
Smith & Nephew
Alajuela, Coyol, CR
hace 1 día

Role Overview : Develops and coordinates product labeling requirements and package graphics for assigned product lines within the Sports Med, ENT, Orthopaedics and Robotics franchises.

Maintains the web-based product labeling database within the Prisym Medica system. Develops and maintains policies and procedures for the creation, review and approval of all product labeling data and the definition of packaging graphic requirements.

Reports to the Director of Global LabelingResponsibilitiesDefines product labeling requirements and package graphics for new products and changes to existing products and reviews all labeling specifications for content and accuracy.

  • Works under general supervision with some opportunities for individual action.Evaluates labeling systems or software to determine the impact of implementation on the business;
  • may recommend system upgrades or enhancements.Coordinates scheduling requirements for labeling system modifications or enhancements.

    Determines system functionality requirements and works with IT and manufacturing to resolve issues related to system performance or data maintenance.

    Coordinates data compatibility with other product data systems, e.g. Matrix and SAP.Develops formatting requirements within the Prisym Medica labeling system.

    Maintains translations to support global labeling requirements in both manufacturing and distribution centers.Works closely with subsidiary manufacturing operations as well as remote distribution locations to define and implement appropriate labeling requirements.

    Assigns training of manufacturing personnel regarding the operation and maintenance of the labeling system.Works with the Regulatory department to ensure that product labeling complies with applicable regulatory and industry requirements, i.

    e. FDA, ASTM, European MDR, Japanese MHLW, etc.Performs text, formatting, illustration and multilingual database audits as required.

  • Facilitates the development and maintenance of labeling guidelines and packaging graphics documentation for the company.Assists the complaint management group in resolving labeling related complaints;
  • initiates necessary corrective actions.Other Job Duties These are additional duties and responsibilities of the position, which may be assigned by the supervisor : Maintains appropriate records regarding product labeling information, system validation, etc.

    Maintains up-to-date knowledge of label printing technology and software developments.Researches technical issues, e.g. bar code technology, to assist management in formulating product labeling strategy.

    Leads improvement projects to resolve issues, improve efficiency or generate cost savings related to labeling.Scope of Job ResponsibilitiesRoutine contact with other S&N departments is required.

    Primarily interacts with Marketing, Product Development, Manufacturing, Quality, Distribution, Information Systems, Regulatory and Customer Service.

    Occasional contact with suppliers, customers, company sales personnel and other company divisions / operations is also required.

    May interact with key surgeons and / or nursing staff in the development of product labeling requirements.Works directly with Marketing, Product Development and Regulatory departments in establishing overall labeling requirements and related compliance issues.

    RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skills and / or abilities required.

    Reasonable accommodation may be made to enable persons with disabilities to perform the essential functions.Education : Bachelor's degree in engineering, computer science, Civil, Industrial, graphic design or related technical area plus four years of relevant experience.

    Experience : Experience in Medical Industry, manufacturing, Foods or related in project, process, regulatory, packaging, labeling or related.

    Must possess strong organization, team leadership, communication and interpersonal skills.Experience with graphics software and MS Access or SQL is preferred.

    Demonstrated knowledge and ability to define scope, plan and execute project tasks with a focus on meeting demanding schedule deadlines.

    Must possess strong organizational, team leadership, communication and interpersonal skills.Ability to communicate effectively in English.

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