Quality Systems Specialist

  • Cork
  • Contract 12 months
  • JO-1908-64708_1567440617

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 in accordance with MEDDEV 2.12-1 current revision.
  • 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 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 worldwide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements
  • Demonstrated proficiency conducting investigations and implementing corrective and preventive actions
  • Ability to work in a cross-functional and matrix environment.
  • Requires organizational and critical thinking skills.
  • Demonstrates ability to respond to the urgent needs of the team, with a proven track record of meeting deadline.
  • Knowledge of basic medical terminology.

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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