Medical Device Auditor (m/f/n)

We are searching as soon as possible for a dedicated and experienced

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Auditing, taking into account the European directives and regulations for medical devices
Supporting our clients to fulfill the European directives and regulations for medical devices
Guiding clients through the registration process for medical devices in the EU
Maintenance of contacts with regulatory authorities (e.g. interactions with notified bodies)

Strong knowledge of regulatory guidelines: 90/385/EEC, 93/42/EEC, 98/79/EEC, 2017/745 (MDR), 2017/746 (IVDR) and EN ISO 13485
Working experience of at least 2 years at a Notified Body
Excellent language skills in German and English (spoken and written); additional language skills would be an asset
Ability to manage multiple and varied tasks within an international team

You will be working in a modern, professional, fast-growing, internationally active organisation with a high degree of responsibility and independence
Intensive on-the-job training will be provided in a competent multidisciplinary team
We support the compatibility of work and family by offering flexible working hours as well as childcare subvention
Our knoell academy offers various training opportunities
We offer the opportunity to participate in the company pension scheme
Under specific conditions you have the chance to participate in the employee participation program

Bettina Cöppicus
Senior Personalberaterin

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Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg