IVDR 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

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.

Key Accountabilities : Auditor

What we offer

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

Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.

Education

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, and / or 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.

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.

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

Skills Required

Iso 13485, Technical Writing