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:
Qualifications & Experience:
- 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
- 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