CLINICAL EVALUATION MANAGER (m/w) – geschlossen

  • Position zu besetzen ab 23. April 2018
  • Permanent-ID OCR-FL-2018-1047
  • Branche Medizintechnik
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 8x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Medizintechnik

Qualifications

  • Fluent in English (plus working knowledge of at least one other European language)
  • Bachelor or higher education ideally in the field of health care

Experience

  • Knowledge of/experience with literature searches, scientific work
  • Beneficial would be knowledge of risk-benefit assessment, pre- or post marketing clinical follow-up
  • Ideally first experience working with Medical Devices according to MDD/MDR and MEDDEV 2.7.1/ISO14155/ISO13485 standards 

Responsibilities

  • Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary
  • Evaluate if there are clinical data available and determine equivalence in case of possible equivalence to an existing device
  • Supports generation of required documentation to initiate clinical trials (CFRs, Protocol, Investigator brochure, …)
  • Generate Clinical Evaluation Reports
  • Execution, communication and reporting of feasibility, CE mark and post-marketing studies to enable the company to meet its business objectives

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