MDR Vigilance Specialist

  • Permanent
  • Location: Galway
  • Ref: 915719

Job Details

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What you need to know

You will work as the MDR Vigilance Specialist for our client, a highly successful and established medical device company in Galway.

You will work alongside the Complaint Handling and Medical Device Regulatory department providing value throughout the Product Life cycle through world-class execution in Medical Device Reporting and Vigilance compliance.

This is a permanent role.

 

Your new job

Key duties & responsibilities:

  • Monitor the organisations drug or medical device surveillance program.
  • Follow-up on complaints & adverse reports, assisting in the resolution of any legal liability ensuring to comply with government regulations.
  • MDRs (Medical Device Reports) – ensure complete & accurate maintenance and reporting as required by regulatory agencies.
  • Liaise internally and externally with collaborators developing programs and processes to meet regulatory reporting requirements.
  • Support the response to any queries received from regulatory agencies concerning complaint events or post-market regulatory reports.
  • Coordinate complaint trend analysis and annual post-market surveillance reports for various products.
  • Work with other sites globally to support complaint handling harmonization initiatives.
  • Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.

What are we looking for?

  • Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline. Please note candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
  • At least 2-years relevant experience in a medical device environment.
  • Dynamic team player who can work effectively and proactively on cross-functional teams.
  • Strong communication skills.
  • Excellent customer service skills.

Desirable

  • Experience of complaint handling or CAPA processes.

 

Apply for this job now or get in touch with Áine on 090 64 90485.

 

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Recruitment Consultant: Áine Clehane

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