Science, Pharmaceutical & Food

MDR Vigilance Specialist

  • Contract
  • Remote
  • Galway
  • 41827867

PE Global are currently recruiting for an MDR Vigilance Specialist on behalf of a leading Medical Device company based in Galway. This is a 12 month contract role.

The Role
The successful candidate will be part of a high performing Complaint Handling & Medical Device Regulatory reporting team within a US Multinational organisation based in Galway – 12 month contract

Responsibilities

  • Co-ordination of complaint handling activities for a wide range of products including receipt and documenting of incoming complaint events. 
  • Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
  • Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
  • Monitoring the company’s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. 
  • Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data
  • Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization
  • Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Education and experience

  • Third level Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline or Compliance physiological or clinical measurement science) will also be considered.
  • 2-4 years relevant experience in a medical devices or related environment.
  • Experience/understanding of complaint handling or CAPA processes are desirable.
  • Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence,
  • Candidates must be a good communicator and are fluent in English, both in writing and speaking.

Please click the link below to apply, call Laura on 0214297900 or alternatively send an up to date CV Laura.obeirne@peglobal.net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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