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)
- A competitive compensation and benefit package
- DNV training and qualification program
- A professional community in a prestigious technological company
- Possibilities to work with interesting and challenging projects
- Access to an extensive competence network
- Social benefits as per DNV location (local conditions apply)
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
Position Qualifications
- Medical Doctor
- At least 2 years of working experience including:
- direct work experience in patient care
- research experience in conducting preclinical or clinical trials or assessing clinical data
- Strong written and verbal English communication skills
Personal Qualities
- Strong technical skills concerning knowledge and experience with medical devices
- Analytical approach
- Good communication skills
- Customer focus
- Excellent reporting skills
- Ability to work independently and efficiently
- Team-oriented mindset
- Ability to recommend on certification in complex cases
- Application deadline: 18.10.26. If you are interested, please submit your CV in English.
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.