Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to

Regulatory Affairs Officer

Reference:A006181 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
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