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Regulatory Affairs Specialist

Job description

As a Regulatory Affairs Specialist, you will drive and/or support key MMS projects My client is Global Medical Devices company based in Limerick.

Job Responsibilities:

  • Inputing to development of regulatory strategies and provideing guidance and expertise.
  • Compiling and communicating regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
  • Preparing and presenting gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.
  • Reviewing and approving the project documentation (design reports, labelling, etc.).
  • Developing tactics supporting first to market commercial opportunities and minimizes time to product launch.

Job Requirements:

  • 3rd level degree in Electronics or Biomedical engineering discipline.
  • 3+ years’ experience in Regulatory Affairs within medical devices industry 
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…)

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

 

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