Medical Device Specialist

5 days ago


Oslo, Oslo County, Norway DNV Germany Holding GmbH Full time
Job Description

At DNV Germany Holding GmbH, we are seeking a highly skilled Internal Clinician to join our team. As an Internal Clinician, you will play a crucial role in ensuring the safety and performance of medical devices.

The main tasks of this role include:

  1. Assessing clinical data provided by manufacturers to ensure compliance with EU Regulations on medical devices and in vitro diagnostic medical devices.
  2. Evaluating the summary of safety and clinical performance reports for high-risk devices.
  3. Reviewing periodic safety update reports provided by manufacturers.
  4. Collaborating with external specialists in different clinical fields during the assessment of clinical data of high-risk devices.
  5. Communicating with manufacturers on clinical data requirements.
  6. Carrying out final approval of clinical evaluation assessment reports and other relevant clinical documentation for accuracy and compliance with the requirements.
  7. Recommending certification based on reviewed documentation.
  8. Performing competence review, training and approval of new colleagues (clinicians).


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