Group Leader - Engineering Medical Devices

 Dr. Knoell Consult GmbH  Berlin, Leverkusen, Mannheim
We have been an independent service provider for the agrochemical and industrial chemical industry since 1996, with currently over 530 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 Health Care team we are currently seeking a
      Group Leader - Engineering Medical Devices (m/f)
      - full-time or part-time with min. 32 hours per week / permanent contract -
      Ref. No. 2017-06/JV
Role and Responsibilities
  • Lead a group of scientists and engineers dealing with:
    - Guidance of clients regarding all regulatory aspects of the life cycle of a medical device, with a focus on the implementation and support for Quality Management Systems as well as the review and preparation of the technical documentation
    - Auditing according to EN ISO 13485 and 93/42/EEC or 90/385/EEC or 98/79/EC
    - Preparation of regulatory documents in compliance with medical devices regulations in Europe and world wide
  • Ensure high level of quality within projects (i.e. reports, expert statements, correspondence, quotations)
  • Communication and close co-operation with our clients
  • Technical contribution to client projects (onsite, if required)
  • Development of the group
  • Build-up, maintain and share the scientific and regulatory knowledge within the group
  • Promote economic thinking and responsible acting within the group
  • Participate in and contribute to the management team
  • Ability to travel locally and internationally, as required
Profile and Qualifications
  • Educated to degree level (engineering / Master of Science) or with an equivalent combination of qualification and experience
  • Strong knowledge of regulatory guidelines: Medical Device Directive (MDD) – Directive 93/42/EEC and amendments and EN ISO 13485, EN ISO 14971, EN ISO 10993 series, EN 60601-1, EN 62304, EN 62366, etc.)
  • Several years’ experience in the field of medical devices
  • Decision-making ability
  • Strong motivation with excellent communication and organizational skills in multinational environment
  • Excellent interpersonal and team playing skills; service oriented personality and attitude
  • Quick learner, able to react to new challenges
  • Very good language skills in English and German (spoken and written); additional language skills would be an asset
  • 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, Leverkusen or Berlin (Germany)

How to apply:
If you are interested, please submit your complete application via our Online-Portal
Kontakt für Bewerbungen
Dr. Knoell Consult GmbH
Human Resources
Dynamostr. 19
D-68165 Mannheim
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 2017-06/JV

Über Dr. Knoell Consult GmbH

Die Dr. Knoell Consult GmbH  ist seit 1996 als unabhängiger Dienstleister mit nunmehr über 560 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...

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