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.

• 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.