Complaint Investigator / Reviewer # JN -032019-45208

Andover, MA

Posted: 03/15/2019 Industry: Biotech / Pharma Job Number: JN -032019-45208
Description:
  • Analyse complaint data and apply appropriate coding to complaint records, linking complaints to product improvements, product defects, and safety evaluations
  • Perform independent technical assessment on product quality complaints and post-market product quality analysis
  • Evaluate complaint data and confirm regulatory reportability decisions and risk assessments performed

Experience / Education:
  • 5 years experience
  • Bachelor s Degree in Biomedical Sciences, or other technical degrees
  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR
  • Medical Device and or other regulated industry (Pharma, IVD,) preferred
  • An organized, analytical thinker with exceptional attention to detail
  • Experience in Complaint Handling and/or Symptom Coding
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