Customer Specialist-Quality

  • Cork
  • Temporary 12 months
  • JO-1907-64625_1562760330

Summary

JOB PURPOSE:
Customer Quality member responsible for completing Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions.

RESPONSIBILITIES:

  • Submission of initial and final vigilance reports
  • Co-ordinating timely responses to competent authorities and health ministry's regarding product performance.
  • Co-ordinating responses to product performance enquiries from surgeons, patients and health care providers.
  • Support litigation cases and co-ordinate the provision of performance data to legal teams
  • Partner with manufacturing sites and design centres to obtain product performance summaries and data.
  • Undertake product performance reviews using available data analysis tools to respond to enquiries.
  • Escalate product performance concerns through the established processes
  • Participate in product risk assessments providing input in order to evaluate patient risk as required
  • Be pro-active in shaping and influencing regulatory environment working with Healthcare Industry body groups and Forums (ABHI, Eucomed etc).
  • Attend meetings with health care regulators as required.
  • Perform all other work-related duties
  • Continuous Improvement Focus
  • Additional activities as deemed appropriate by the Complaints Manager.

Requirements:

  • A minimum of a Bachelor's Degree is required.
  • Regulatory/Quality Systems experience
  • 3+ years Medical Devices Industries experience
  • Broad experience and knowledge of world-wide quality system regulations (e.g. FDA & ISO) with a working knowledge of international Health Authority reporting requirements
  • Demonstrated proficiency conducting investigations and implementing corrective and preventive actions

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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