Sharon Kiely

Manager - Contract and Temp Division

T: +353 61 578 977 E: skiely@azon.ie
  • SectorConstruction & Engineering
  • LocationLimerick
  • SalaryUp to €40000.00 per annum
  • Posted onJune 26, 2020
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The RA specialist will support a broad range of projects for infusion pumps, embedded or stand-alone software, pump accessories or infusion sets. He/she will participate in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).

Key Responsibilities:

  • 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.
  • Reviews and approves the project documentation (design reports, labelling, etc.).
  • Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.

Qualifications:

  • BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.
  • Minimum of 2 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 13485, ISO 14971 and IEC 60601 series).
  • Knowledge of FDA regulatory requirements is a plus.

Please note: If you are an EU/EEA national, you will be asked to show proof of right to work e.g. showing your employer a copy of your passport.

If you are a non-EU/EEA national, you will require current and valid permission to work and reside in the EU/EEA. Information on legislation and guides to the procedures in relation to obtaining Green Card Permits, Work Permits, Spousal/Dependent Permits is available on the Department of Jobs, Enterprise, and Innovation website.

Sharon Kiely

Manager - Contract and Temp Division

T: +353 61 578 977 E: skiely@azon.ie

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