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Details

Regulatory Affairs Specialist


Reference:JCHQ00000290 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs


Regulatory Affairs Specialist
Our client a multinational medical device company currently seeks a Reg Affairs Specialist to join their team. Successful candidate will be required to work in the Regulatory Affairs area to ensure that the area runs in a smooth and efficient manner. Function will involve a thorough understanding of both the clinical trial and regulatory requirements required for the Medical Device Industry.

Role/Responsibilities:



  • Responsibility for structuring and managing technical files.

  • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820

  • Responsibility for product registration in the EMEA, and other markets as appropriate.

  • Responsibility for registration of all Class I devices with the Irish Medicines Board.

  • Member of the new product introduction and design control teams.

  • Liaison with the Notified Body and other relevant authorities.

  • Responsibility for handling regulatory affairs related queries.

  • Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.

  • Responsibility for review and approval of validation and verification documents from a regulatory view point



Skill/Experience



  • Third level Qualification in Science/Quality, at least 5 years experience in a regulated industry in a similar role.

  • Thorough knowledge of the EU, MDD and EMEA requirements.

  • Thorough knowledge of the RA requirements in the GHTF countries.

  • Knowledge of medical device quality standards/practises or similar regulated industry

  • Good communication and inter-personal skills.

  • Proven problem-solving skills.

  • Good computer skills including knowledge of Microsoft® Office.

  • Proven organisational skills.

  • High self-motivation.

  • Approved External Auditor.

  • Willingness to travel on company business



If you would like further Information you can contact the recruiter directly:

James Cassidy | Tel: +353 (0) 1 5079250