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Vacancy Details

Science Pharmaceutical and Food

106712 - Regulatory Affairs Analyst - Clare

Contract Type: Permanent
Location: Clare
Date: 16/01/2020
Job Reference: 106712
Contact Name: Clara Burke
Contact Email:

Job Description

Regulatory Affairs Analyst - Clare - 106712
Regulatory Affairs Analyst

Our client a pharmaceutical company in Clare is looking to recruiter a Regulatory Affairs Analyst for their site.

  • RA representative on Design Change projects.
  • Preparation and maintenance of CE technical files in compliance with current IVDD and preparation for compliance to new IVDR.
  • Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
  • Management of Field Action process for AU products.
  • Review and approval of device modification proposals.
  • Review and approval of all product labelling.
  • Control of distribution of product from regulatory perspective through regulatory stop ship program
  • Participation in Internal and External Quality Audit as required.
  • Participation in Management Reviews of the Quality & Environment System as required.
  • Communication to management on Regulatory affairs issues, which require addressing.
  • Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the company.

Education/ Experience
  • Qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.
  • Have a minimum of 1 years’ experience in a QA or RA role within a manufacturing facility.
  • Excellent written and communication skills are essential, which will result in strong working relationships cross functionally.
  • Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands.
  • Knowledge and understanding of the IVDD Directive and the associated harmonised standards.
  • Knowledge and understanding of ISO13485 and the FDA QSRs.
  • Experience of product registrations is desirable.

For further information on this Regulatory Affairs Analyst role in Clare please contact Clara Burke on 0868168273/

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Hollister ULC, Ballina, Co. Mayo

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