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EU MDR Labeling Administrator - IRE-1 in Carrigtohill at Stryker Corporation

掲載日付: 11/22/2018


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EU MDR Labeling Administrator

Position Summary:

Support language translations for medical device labeling and support label and Instructions for Use (IFU) needs related to translation management and compliance. As a member of the Technical Publications team, support R&D Business Units and Regulatory Affairs to meet requirements for global product distribution.

Your key responsibilities:

  • Modify medical device labeling to make them compliant to the new EU Medical Device Regulations per direction of a project lead.
  • Use specialized labeling software to create/modify label formats and enter label content into a structured database.
  • Change out label stock in label printers.
  • Conduct label bar code verification/grading activity.
  • May prepare cover letters and send label content to an external service to obtain language translations for labels.
  • Prepare associated engineering document which presents label and associated label material.
  • Proofread modified labels/engineering print for self and other team members verifying that content is properly updated per inputs.
  • Support change management documentation workflows in PLM system to archive labels.
  • May support related regulatory product Technical Documents to identify completed sets of labels associated with specific product groupings to provide evidence of compliance.
  • Meet project milestones. The project is time-sensitive. Grouped assignments will be deadline driven.
  • Support multiple simultaneous translation projects for product labels and Instructions for Use (IFUs). Facilitate software engineers with translations of graphical user interfaces (GUI).
  • Support translation strategies that satisfy international labeling needs for Business Units including Mergers & Acquisitions.
  • Inform new product development teams on relevant aspects of the translation process such as requirements, costs, and timelines.
  • Report to internal customers level of risk for “at-risk” investment of pre-approved English text and communicate impact of language translation for alignment with project timelines.
  • Process language translations in an efficient and timely manner through collaboration with an external translation service. Report estimates, and costs associated with translations to manager.
  • Review labels and IFUs for completeness and presentation.
  • Utilize a variety of specialized software to support labels and IFUs: desktop publishing, specialized label software, translation management software, PLM/CMS system for labeling releases/updates. Perform troubleshooting of electronic files as needed.
  • Work closely with label designers to create and maintain new and legacy product labels.
  • As needed, engage in support activities related to publication of IFUs to eIFU website.
  • Initiate/assist with departmental continuous improvement endeavors.
  • Track data/metrics associated with translation projects.
  • May assist with internal and external regulatory audits.
  • May provide reviews of regulatory documents to ensure medical device labeling references are correct.

What are we looking for?

  • Bachelor’s Degree or equivalent.
  • 0-3 years translation/ labeling project management experience.
  • Strong organizational and time management practices.
  • Excellent written and verbal English communication.
  • Proven ability to manage multiple simultaneous projects.
  • Detail orientation with the ability to multitask.
  • Solid problem solving and analytical ability.
  • Strong computer skills.
  • Solid database data entry.
  • Experience with content management systems (such as PTC Windchill).

Work From Home: No

Travel Percentage: None