Medical Device Auditor (m/f/n)

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

Medical Device Auditor (m/f/n)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Großraum Mannheim

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    24453

  • Aktualisierung:

    01.02.2019

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Your tasks

  • 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)

Your qualifications

  • 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

Your benefits

  • 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

Ihr Ansprechpartner

Bettina Cöppicus
Senior Personalberaterin

Anschrift

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