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Consultant Medical Device Software

 knoell Germany GmbH  Mannheim, Leverkusen

We have been an independent service provider for the agrochemical and industrial chemical industry since 1996, with currently over 560 employees at sites in Europe, Asia and the USA. As a leading service provider with an international focus, we offer comprehensive advice on the registration of agrochemicals, biocides, industrial chemicals, veterinary pharmaceuticals, medical devices and biotechnological pharmaceuticals.


To support our team we are currently seeking a

   Consultant Medical Device Software (m/f)
   
- full-time or part-time with min. 32 hrs/week/5days and permanent contract -
   Ref. No. 2018-02/JV


Role and Responsibilities
  • Guiding clients through the development and registration process for medical device software in the EU
  • Developing / compiling technical files and design dossiers in compliance with respective regulatory standards of the EU
  • Maintenance of contacts with regulatory authorities (e.g. interactions with notified bodies)

Profile and Qualifications
  • Strong knowledge of regulatory guidelines: EN 62304, EN 62366, EN ISO 14971, 90/385/EEC, 93/42/EEC, 98/79/EEC and EN ISO 13485.
  • Working experience of at least 5 years in the Medical Devices sector
  • 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
  • Ability to travel locally and internationally, as required. Ability to work at the client’s site, as required

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

Location   Mannheim or Leverkusen (Germany)


If you are interested, please submit your application via our Online-Portal
https://www.knoell.com/en/careers/job-offers
https://www.knoell.com/de/karriere/stellenangebote

 
Kontakt für Bewerbungen
Dr. Knoell Consult GmbH
Human Resources
Dynamostr. 19
D-68165 Mannheim
www.knoell.com
 
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 2018-02/JV

Über knoell Germany GmbH

Die knoell Germany GmbH  ist seit 1996 als unabhängiger Dienstleister mit nunmehr über 570 Mitarbeitern an Standorten in Europa, in Asien und in den USA aktiv. Als industrienaher Dienstleister mit internationaler Ausrichtung bieten wir umfassende Beratung in der Registrierung von Agrochemikalien, Bioziden, Industriechemikalien, Tierarzneimitteln, Medizinprodukten und biotechnologischen...

Mehr über die knoell Germany GmbH

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