Label and IFU Administrator in Cork at Stryker Corporation

Date Posted: 2/23/2020

Job Snapshot

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Job Description

Position Summary

  • The Label & IFU Administrator will be responsible for the creation, approval and release of Product Labels as well as the content modifications and all necessary documentation associated with our Product Labels & Instructions for Use (IFU).

Key Areas of Responsibility

  • Responsible for label template and label content design and approval.
  • Support of the Advanced Operations team to deliver the new Product label requirements and the sourcing of new Product IFU’s where applicable.
  • Support of the Labelling Group on strategic projects to update and release our Product Labels in line with any internal or external regulatory requirements.
  • Modification to existing label templates and label content to support the on-going daily business needs (where required).
  • Ensure all Labels and IFU’s, either new or modified, are subject to the appropriate change control processes (ECR/ECN) in conjunction with QA / RA and have full responsibility for final sign off and release into production.
  • Must provide direction to the business units on labelling regulatory requirements including: FDA requirements for packaging and labelling & CE marking.
  • Arrange the outsourcing of any translations required for either Product Labels or IFU’s for specific country requirements.
  • Responsible for the IFU modification form generation and the routing and co-ordination of the required approvals.

Qualifications Knowledge Skills

  • 3rd Level qualification or equivalent industrial experience in pharma or medical device environment.

•Relevant labelling experience, preferably within a regulated environment an advantage but not essential.

  • Knowledge of Prism ID systems and other labelling systems would be a distinct advantage.
  • Knowledge of RA/ QA and FDA requirements for packaging and labelling.
  • Strong organisational and project coordination skills.
  • PC literate and strong knowledge of Microsoft Office tools are essential.

Work From Home: Occasional

Travel Percentage: 10%

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