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Regulatory Affairs Officer

Location: Limerick
Experience:2-3 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Regulatory Affairs

Regulatory Affairs Officer

This company are exclusively sourcing a Regulatory Affairs Officer based in Limerick. The ideal candidate will have a degree in molecular science with the ability and confidence to undertake all associated responsibilities. This role will also involve R&D Liaison with R&D teams.

Roles & Responsibilities

  • Coordination of post market surveillance/vigilance reporting for CE-IVD marked products.
  • Coordination of risk management activities and documentation for CE-IVD marked products.
  • Communication of specific regulatory requirements and provide regulatory support to cross functional teams.
  • Review and approval of Labelling (labels, Instructions for use, marketing material) for compliance with applicable regulatory requirements and international standards.
  • Assist in preparation & maintenance of technical files for CE-IVD marked products and all other relevant documentation required to comply with the In vitro Diagnostic Directive, EU-IVDR and any other national or international regulations which apply to the company.
  • Assists in planning and preparation of regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
  • Preparation of regulatory reports for management as required.
  • Performs additional duties as assigned.

Skills & Experience

  • Minimum BSc
  • Min 2 years' experience in a regulated industry in a similar role.
  • Good Knowledge & understanding of IVD/MD Directive and IVD/MD Regulation
  • Good Knowledge & understanding of ISO 13485
  • Good Knowledge & understanding of FDA 21CFR Part 820
  • Ability to work on own initiative.
  • Self-motivated and enthusiastic
  • Excellent interpersonal skills
  • Effective team worker
  • Good command of English language (written & verbal)
  • Good command of computer packages (e.g. MS Office)

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

Libby Ryan | Tel: +353 (0) 1 507 9254


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