Posted:1 day ago|
Platform:
On-site
Full Time
DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices.
Main tasks in this role are:
Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746.
Evaluation of the summary of safety and performance reports for high-risk IVD medical devices.
Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746.
Education and Competencies required:
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.
Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices.
A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation.
Personal Qualities:
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.
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