Assoc. Specialist, Quality Compliance
Edwards Lifesciences
Valencia, Spain
hace 6 días

Role Purpose Fulfill applicable medical device regulations in the region, ISO13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.

Job Functions Investigate complaints with the support of higher level team member or manager

  • Evaluate event to determine if it qualifies as a complaint
  • Manage customer relationship and expectations during course of complaint investigation and resolution process
  • Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
  • Evaluate complaints for Medical Device Vigilance (MDV) to competent authorities
  • Prepare and submit MDV reports to CA, after review by more senior team member
  • Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and / or training materials, and formulate conclusions
  • Prepare and submit final customer correspondence, after review by more senior team member
  • Other incidental duties; May identify problems with processes, procedures, and / or practices, and recommend solutions, including devising new approaches to problems encountered
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