IVDR Clinical Assessor

As an independent expert in assurance and risk management, we are dedicated to safeguarding life, property, and the environment. Our purpose is to provide reliable insights and empower customers and stakeholders to make critical decisions with confidence. With a reputation as a trusted voice for some of the world's most successful organizations, we strive to advance safety, set industry benchmarks, and develop innovative solutions to address global challenges. At SCPA, we assist customers in meeting the growing demand for trust and transparency in their products, assets, supply chains, and ecosystems. We drive transformation within the assurance industry by certifying products, sharing claims, and optimizing supply chains to help companies manage risks and achieve long-term strategic objectives. Our expertise allows us to bridge trust gaps globally among consumers, producers, and suppliers, ultimately enhancing ESG performance and delivering sustainable results. Joining DNV Product Assurance AS as a Clinical Assessor, you will play a crucial role in assessing the performance data that supports the safety and efficacy of In-Vitro Diagnostic (IVD) medical devices. Your responsibilities will include evaluating clinical performance aspects of legal manufacturers" technical documentation in compliance with Regulation (EU) 2017/746. Additionally, you will review and approve performance evaluation reports for high-risk IVD devices, ensuring accuracy and adherence to regulatory requirements. To excel in this role, candidates must hold a technical college degree in a relevant field such as Biology, Chemistry, Human Physiology, Medical Technology, Medicine, Biomedical Science, Nursing, Pharmacy, Pharmacology, or Physiology. A minimum of 4 years of full-time work experience in the In-Vitro diagnostic medical device industry, academia, or hospital settings is required, with at least 2 years focused on assessing performance evaluation data or conducting related studies. Alternatively, a PhD in a relevant area can substitute 3 years of work experience, provided it includes 2 years of experience in performance evaluation. We offer a competitive compensation and benefits package, comprehensive training programs, and the opportunity to collaborate on exciting and challenging projects within a prestigious technological company. You will have access to an extensive competence network, flexible work arrangements for better work-life balance, generous paid leaves, medical benefits, pension and insurance policies, training and development assistance, and additional perks like long service awards and mobile phone reimbursement. As a successful candidate, you should possess an analytical approach, strong communication skills, a customer-centric mindset, excellent reporting capabilities, and the ability to work independently and efficiently. Your role will involve forming recommendations on certification in complex cases, contributing to the advancement of safety and performance standards in the IVD medical device industry.,