Clinical Evaluation Manager

Feladatok: Responsible for evaluating clinical data for Medicontur's medical devices, developing and updating documentation of clinical evaluation and post-market clinical follow-up, andScientific and regulatory content writingUpdate clinical evaluation plans, clinical evaluation reports to assess safety and clinical performance clinical data;Perform post-marketing surveillance activities, review and write PMS documentation;Update PMCF plans and reports, summaries of safety and clinical performance;Conducts active PMCF activities (e.g. PMCF investigations);Develop clinical investigator brochures presented to regulatory authorities;Interfaces with regulatory affairs, risk management, clinical study site personnel, competent authorities;Develop and update QMS procedures and document template...