IVDR Clinical Assessor

About Us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

About The Role

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
  

What we offer

• 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 share.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.
  

About You

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.