Internal Clinician

This position has continuous, ongoing recruitment efforts for current and future openings. Applying for this role will gain you consideration for all roles within this opening which you are qualified for.

DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. The unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market.

The role of Internal Clinician is to assess clinical data supporting safety and performance of devices.

Main tasks in this role are:

• Approval of Certification Proposals for medical devices to be certified according to the Medical Device Regulation
• Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
• Evaluation of the summary of safety and clinical performance reports for high-risk medical devices
• Review and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the Medical Device Regulation
• Recommend for certification based on reviewed documentation
• Communication with the customers with regards to requirements, status and clinically relevant aspects
• Performing competence review of new resources (clinicians)
• Plan and execute assessment of clinical data as required, within agreed timescales and economic budget