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Regulatory Affairs Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Munster
  • Sector: Science
  • Date posted: 24/04/2018
  • Job reference: J384503A

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Regulatory Affairs Specialist

My client, a leading medical device organisation based in the west is currently seeking a talented regulatory Affairs professional to join their team. In this role you will be the regulatory affairs representative on IDP and Design Change projects and will be involved with the development and implementation of registration strategies for new product launches.

Key Task and Responsibilities:

  • Preparation and submission of 510k for US clearance.
  • Preparation and maintenance of CE technical files in compliance with current projects and preparation for compliance to new projects.
  • 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.

Education/ Experience:

  • Will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.
  • Have a minimum of 3 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 to better serve our internal customers, external customers and legislative demands
  • Knowledge and understanding of ISO13485 and the FDA QSRs.
  • Experience of 510K preparation and product registrations is desirable.
  • Experience of design control assurance desirable.

For more information on this and similar opportunities please contact Kathryn on 016455250 or email