Integrated Clinician

DNV Group; Netherlands; Remote; EUR 65,000 - 90,000; Full time

Job summary

DNV Product Assurance AS in the Netherlands seeks an Internal Clinician to assess clinical data supporting the safety and performance of medical devices under MDR. You will review clinical evidence and prepare assessment reports to demonstrate compliance.

The role includes approving certification proposals, evaluating clinical evaluation reports, planning assessments within timescales and budgets, and communicating with clients on requirements and clinically relevant aspects.

Responsibilities

• Approval of Certification Proposals for medical devices to be certified according to the MDR
• Perform assessment and prepare reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the MDR
• Plan and execute the assessment of clinical evaluation, within agreed timescales and economic budget
• Evaluate and validate 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 MDR
• Recommend for certification based on reviewed documentation
• Communication with the customers with regards to requirements, status and clinically relevant aspects
• Perform competence review of new and existing resources (clinicians)

Job description

DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. Unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation (MDR) 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 MDR
• Perform assessment and prepare reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the MDR
• Plan and execute the assessment of clinical evaluation, within agreed timescales and economic budget
• Evaluate and validate 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 MDR
• Recommend for certification based on reviewed documentation
• Communication with the customers with regards to requirements, status and clinically relevant aspects
• Perform competence review of new and existing resources (clinicians)