ICDS RECRUITMENT

ICDS RECRUITMENT

LABELING COMPLIANCE LEAD


Posted on:
23/04/2020
Location:
WATERFORD
Salary:
NEGOTIABLE
Job type:
CONTRACT
Job reference number:
15498412
Client ID:
SF16998
Benefits:
CAR PARKING, PAID HOLIDAYS, PENSION / PRSA
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