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Regulatory Affairs Specialist

Reference:RH A008689
Location: Limerick
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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Regulatory Affairs Specialist required for a Limerick based Medical Device facility.

We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Inputs to development of regulatory strategies and provides guidance and expertise.
  • Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
  • Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.
  • Reviews and approves the project documentation (design reports, labeling, etc.).
  • Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.

Education and Experience:
  • A relevant degree and have 3+ years’ experience in a similar position.
  • Experience working on regulatory submissions with exposure to programmable electrical equipment. Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…);
  • Knowledge of FDA and international regulatory requirements is a plus.

For more information contactRuth Hollandon087 7822


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