Job Details

  • Title: Medical Writer
  • Code: RCI-ABT-79857
  • Location: Princeton New Jersey (NJ) 08540
  • Posted Date: 10/10/2019
  • Duration: 6 Months
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  Job Description

Job Description

Medical Writer for Regulatory Submissions

  • Regulatory experience with IVDs (in vitro diagnostics), then medical devices
  • Experience with 510k submissions
  • Prepares technical documents to support both domestic and international regulatory submissions.
  • Incorporates text, graphs, charts, tables, and statistical analysis.
  • Writes, proofreads, circulates, edits, assembles, inspects, and duplicates product submissions.
  • Requires a life-science degree and 7 years writing experience with IVDs or medical devices.
  • Must have demonstrated ability to understand and summarize analytical studies required for regulatory submissions of IVDs or Class II Medical Devices.
  • Qualified candidates need to have experience writing technical documents to regulatory agencies, including FDA.
  • These documents may include study reports, study protocols, clinical reports.