Stryker EU MDR Labeling Administrator - IRE-1 in Carrigtwohill, Ireland
EU MDR Labeling Administrator
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
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com