Medical Device

vor 3 Wochen

Dresden, Deutschland DNV Vollzeit

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 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 :
• 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

• 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


If you are interested, please submit your CV in English.

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:
o direct work experience in patient care
o research experience in conducting preclinical or clinical trials or assessing clinical data
• Strong written and verbal English communication skills
Personal Qualities:
• Strong technical skills
• Analytical approach
• Good communication skills
• Customer focus
• Excellent reporting skills
• Ability to work independently and efficiently
• Ability to recommend on certification in complex cases

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