your search starts here

Apply for this job

























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 applications@lifescience.ie

Regulatory Affairs Officer

Reference:A006181
Location: Limerick
Qualification:Degree
Experience:2-3 Years
Job Type:Permanent
Salary:Not Disclosed
apply for job
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




Apply

contact info


search


job tools

login to your account

forgot your password? click here