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Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Regulatory Officer


Reference:KS/AKLW-532705 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Life Science Recruitment are exclusively sourcing a Regulatory Officer for our client who are based in Limerick. The ideal candidate will have a BSc in molecular science with the ability and confidence to undertake all associated responsibilities.

Role/Responsibilities:

  • Prepare and maintain IVDR compliant technical files utilising information from cross functional teams.
  • Review and approve project documentation and participate in R&D phase reviews across multiple projects.
  • Coordinate risk management activities and file preparation.
  • Communicate specific regulatory requirements to cross functional teams.
  • Input into development of regulatory strategy under IVD Regulations.
Education/Experience:

Essential Criteria:
  • Min 3 years’ experience in a Medical Device/In Vitro Diagnostic Device Company
  • Excellent working knowledge of ISO 13485 and ISO 14971 standards and Medical Device legislation; MDD/MDR experience welcomed, IVDD/IVDR preferred.
  • Experience in preparation of medical device technical files and regulatory submissions
  • BSc in molecular biology or related discipline Ability to work to tight deadlines Good initiative and team player
Desirable Criteria:
  • PhD in molecular biology or related discipline Experience with QMS and product audits from Notified Bodies Good problem-solving skills