- Title: Medical Writer
- Code: RCI-ABT-79857
- Location: Princeton New Jersey (NJ) 08540
- Posted Date: 10/10/2019
- Duration: 6 Months
Talk to our Recruiter
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
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.