Job Description

Labeling Compliance Lead

Ref No: SF16998

Waterford, Co. Waterford, Ireland

Competitive salary

Labeling Compliance Lead

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

Core Purpose:

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

Core Responsibilities:

• Develop MDR Labeling Compliance requirements for all contact lens 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 EU who accept CE marked product.
• Project management of the MDR Labeling Compliance deliverables.
• Perform gap assessment against the required standards for the labelling portfolio for contact lens.
• Remediate gaps for labelling for contact lens.
• Work with cross functional site teams on the implementation of labelling requirements for all products within scope.
• Ontime delivery of the schedule.
• Change management activities for the implementation of MDR labelling requirements.
• Other duties as assigned by CL MDR project lead

Qualifications & Experience:

• Third level Qualification in Science or Engineering
• Knowledge of labelling regulations
• Previous experience of implementing labelling/packaging changes
• New product introduction (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. Kintana, D2, ELM )
• 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
• CGMP experience