Clinical Evaluator - South Africa
Beier Group Pty Ltd
Applications from suitably qualified candidates are invited to apply for the Independent Contractor position of Clinical Evaluator to be based at Beier Drawtex Healthcare in Pinetown. Responsible for preparing Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Clinical Follow Up Reports and other clinical documentation as required for CE marked devices Responsible for writing Clinical Investigation Plans Provide clinical input into product development projects Consistently provide feedback on updates to clinical regulatory requirements and related standards / guidelines Relevant medical degree or science degree 5 years of documented professional experience or 10 years of professional experience if no relevant degree is present. Working experience with wound care/ wound dressing or related device technologies Knowledge of research methodology – clinical investigation design and biostatistics included Experience and application of medical device regulations (MDR 2017/745; 21CFR820; Act 101 of 1965, etc) and related guidance documents and standards (ISO 14155) Experience in medical writing, conducting systematic review and clinical data appraisals Always keeping the end-user/ safety of patient in mind Ability to develop good working relationships and trust with various teams Facilitation skills Attention to detail Business acumen Integrity when handling confidential information Excellent scientific writing / report writing skills Communication skills (written and verbal)
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