Job Description

Labelling Compliance Lead

Ref No: AM16998

Waterford, Co. Waterford, Ireland

Competitive salary

Labelling Compliance Lead.

This role is being offered as a 2 year fixed-term contract.

In this role you will manage the labeling strategy, changes and activities for the implementation of MDR for all sites.

Principal Responsibilities:
Develop Labelling compliance requirements for all sites within scope of the project.
Create a strategy for the implementation of MDR labelling requirements.
Liaise with cross-functional teams on the strategy.
Communicate with stakeholders ensuring acceptance of labelling changes in regions outside the EU who accept CE marked product.
Project management of the labelling compliance deliverables.
Perform gap assessment against the required standards for the labelling portfolio.
Remediate gaps for labelling.
Work with cross-functional site teams on the implementation of labelling requirements for all products within scope.
On time delivery of the schedule.
Change management activities for the implementation of MDR labelling requirements.

Interested applicants should have:
Third level Qualification in Science or Engineering
Knowledge of labelling regulations
Previous experience of implementing labelling/packaging changes
New product introduction experience is an advantage
Cross-functional project team management
Working knowledge of MS project
Working knowledge of change management systems/processes.
Experience Project Manager
Working knowledge of packaging and labelling processes
Working knowledge of global QMS systems (e.g. document and change management systems)

Good communication skills ( verbal & written )
Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach.
High attention to detail
Medical Device or pharmaceutical experience

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