IVDR Assessor/Auditor

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 Life Sciences We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017⁄746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Assessor Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. Auditor Responsible to carry out audits of the manufacturer’s quality management system (QMS) and of its suppliers and/or subcontractors when appropriate, and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. A stimulating and diverse work environment with opportunities for professional growth and development – learn from highly skilled colleagues and customers Social benefits as per DNV location (local conditions apply) 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. Position Qualifications: Assessor/Auditor ~ Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.

Genetic testing Human Physiology Medical Technology or Biotechnology Biomedical science - e.g. haematology, virology, molecular diagnostics In addition to a relevant educational degree, 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 design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, as well as experience as an assessor or auditor in a notified body. Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. ~ A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.

An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques; Work experience in positions with significant QA Regulatory or management systems responsibility; Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices; Experience with Risk Management EN ISO 14971; Medical device experience from auditing/work; Experience auditing against recognized standards; Experience of working under own initiative and in planning and prioritizing workloads; Should have a flair for technical writing, essential for exhaustive report writing.