Cache of job #14122043

Job Title

Labeling Compliance Lead

Employer

ICDS RECRUITMENT

Location

WATERFORD

Description

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.

Date Added

1341 days ago

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