Regulatory Affairs Clinician

5 days ago


Oslo, Oslo County, Norway DNV Germany Holding GmbH Full time
Key Responsibilities

As an Internal Clinician at DNV Germany Holding GmbH, your primary responsibility will be to assess clinical data supporting the safety and performance of medical devices and/or in vitro diagnostic medical devices. You will also be required to evaluate the summary of safety and clinical performance reports for high-risk devices and collaborate with external specialists in different clinical fields during the assessment of clinical data of high-risk devices.

In addition to these key responsibilities, you will be expected to communicate with manufacturers on clinical data requirements, carry out final approval of clinical evaluation assessment reports and other relevant clinical documentation for accuracy and compliance with the requirements, and recommend certification based on reviewed documentation.



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