Our client, a medical device company in Limerick are currently looking to recruit a Label and DFU Administrator for their Castletroy site.
The Label & DFU 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 & Directions for Use (IFU).
Your key responsibilities
- Ensure all label sources are created and delivered to the required standard labelling processes.
- Responsible for label template and label content design and approval.
- Re-work existing device, package, and other labels where required to ensure they meet the template labelling standards.
- Support of the Advanced Operations team to deliver the new Product label requirements and the sourcing of new Product DFU’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 labels and label content to support the on-going daily business needs (where required).
- Ensure all Labels and DFU’s, either new or modified, are subject to the appropriate change control processes in conjunction with QA / RA.
- Work with the Labeling Team to ensure all labelling meet regulatory requirements including: FDA requirements for packaging and labelling & CE marking.
- Work with the existing labeling team to arrange the outsourcing of any translations required for either Product Labels or DFU’s for specific country requirements.
- Responsible for the DFU, and other label modification form generation and the routing and co-ordination of the required approvals.
- 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 Adobe Suite, including, Illustrator, InDesign, Acrobat, Photoshop.
- PC literate and strong knowledge of Microsoft Office tools are essential.
- Knowledge of RA/ QA and FDA requirements for packaging and labelling.
- Strong organizational and project coordination skills.
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