IVDR Clinical Assessor
IVDR Clinical Assessor
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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:
- Clinical Assessors shall have a technical college degree in a relevant product or medical area as described below.
- Biology or Microbiology
- Chemistry or Biochemistry
- Human Physiology
- Medical Technology or Biotechnology
- Medicine Veterinary Medicine
- Biomedical science - e.g. haematology virology molecular diagnostics
- Nursing
- Pharmacy Pharmacology Toxicology
- Physiology
Responsibilities
- 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
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Annual Sick Compassionate Local Public Marriage Maternity Paternity Medical leave)
- Medical benefits ( Insurance and Annual Health Check-up)
- Pension and Insurance Policies (Group Term Life Insurance Group Personal Accident Insurance Travel Insurance)
- Training and Development Assistance (Training Sponsorship On-The-Job Training Training Programme)
- Additional Benefits (Long Service Awards Mobile Phone Reimbursement)
- Company bonus/Profit 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.
Qualifications
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:
- Analytical approach.
- Strong communication skills.
- Customer focus.
- Excellent reporting skills.
- Ability to work independently and efficiently.
- Ability to form recommendations on certification in complex cases.
Employment Type
Full-Time
