Reg Affairs Specialist

  • Type: Permanent
  • Location: Clare
  • Salary: Negotiable
  • Job Ref: RA52365
  • Date Posted April 14, 2020

Harmonics Recruitment are hiring for a Reg Affairs Specialist for a growing MNC in the Mid West

Responsibilities:

  • RA representative on Design Change projects.
  • Preparation and maintenance of CE technical files and 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 labeling.
  • 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.

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 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 within the organisation
  • 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.
More Details

For more information on this position please call Lee-Ann Enright at leeann@harmonics.ie.

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