DNV Product Assurance AS is one of the leading Notified Bodies for medical devices and our Central Europe Medical HUB is a partner of NB providing the medical services to the customers. Medical HUB is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market.
As part of our continued growth, we are looking to recruit a technical and experienced Active Medical Device Assessor / Lead Auditor in Europe. The successful candidate will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Medical Assessor / Auditor shall have a technical college degree in a relevant product or medical area, as described below.
In addition to a relevant educational degree, the candidate must have a minimum 4 years’ work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).
As part of this work experience, risk management experience should be covered:
A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.
To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:
In addition to the above you’ll also need to demonstrate the following;
There are plenty of opportunities for personal growth through our 70-20-10 philosophy (70% learning on the job, 20% coaching and 10% training) and an individual career development plan in long term.
The position is rewarded appropriately, including fringe benefits such as:
DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.
Whether certifying products, verifying 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.
Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.
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