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Clinical Evidence Specialist (Remote)
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- For established products in the EU market, writes post-market clinical follow-up (PMCF) plans and documents safety and performance outcomes in the PMCF Evaluation Report in support of MDR.
- Draft and assemble documentation as required for internal records and regulatory submissions.
- Education and/or experience equivalent to a Bachelors' Degree in the medical, nursing, biological, physical or engineering disciplines.
- A minimum of three years of clinical research, clinical study, clinical data synthesis/analysis and/or clinical writing experience in the medical device field, preferably related to PMCF data collection and reporting.
- Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs.
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