RA Specialist

Job description

RA Specialist

The RA specialist drives / supports key MMS projects in which regulatory affairs is a critical component component of driver. This role applies to a broad portfolio of products including Infusion Pumps (Programmable Electrical Medical Devices), stand-alone software as medical device, and disposable infusion sets. This role is full-time, permanent and is based in Limerick.  

As the RA Specialist you will have:

  • Inputs to development of regulatory strategies and provides guidance and expertise
  • Complies and communicates regulatory requirement (e.g MMD / 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
  • Review and approves the project documentation (design reports, labelling etc.)
  • Develop tactics supporting first to market commercial opportunities and minimizes time to product launch


The successful candidate will have:

  • BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience
  • Minimum of 3 years’ experience in Regulatory Affairs within medical devices industry with exposure to programmable Electrical equipment.
  • Alternatively, a strong technical experience in the field of Programmable Electrical Medical Systems including exposure to regulatory affairs requirements.
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO and IEC
  • Knowledge of FDA regulatory requirements is a plus


If you would like to discuss this role, please reach out to Louise Whitty on 021 2359140 /

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