Connecting...

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 / lwhitty@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.