IVDR Assessor / Auditor

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.

Key Accountabilities : Assessor

• Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
• If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation / approval requirements.
• Conduct Technical File reviews specific for products being authorized.

Key Accountabilities : Auditor

Our working culture is based on respect for one another and the appreciation of work-life balance.

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.

Position Qualifications : Assessor / Auditor

In-Vitro Diagnostic devices :

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. Specifically :

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.

In addition to the above, knowledge of the following would be preferred :

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.