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Director (f / m / d) Quality and Regulatory Affairs

Director (f / m / d) Quality and Regulatory Affairs

EVIDENT Europe GmbHHamburg, Germany
Vor 7 Tagen
Anstellungsart
  • Quick Apply
Stellenbeschreibung

Aufgaben

  • As Director Quality and Regulatory Affairs (m / w / d) you support business units and functions in creation, implementation and maintenance of processes and related documented information.
  • You are accountable for the effectiveness of the quality management system and corresponding certifications for the EMEA sales organisations.
  • You will be responsible for regulatory compliance
  • You will be responsible for product registration in EMEA countries
  • You are in charge of the implementation of Field Safety Corrective Actions in the EMEA region
  • You ensure post market surveillance obligations are fulfilled according to the relevant regulations
  • You will be leading a team of 4
  • You need to be based in the Hamburg office

Qualifikation

  • You have a university degree or similar qualification
  • You describe yourself as an experienced QMRA Lead
  • You have a proven knowledge of ISO 9001 : 2015 / ISO 13485 : 2016 and IVDR
  • Ideally you have a background knowledge of Laser and X-Ray regulations
  • You bring a business driven attitude
  • Your communication skills are excellent and you are able to effectively communicate across all levels of the EMEA organization and work productively with others in a team environment
  • You are fluent in English and German language. Further languages skills are a plus
  • Risk management knowledge is a plus
  • You need to be based in Hamburg and will travel to other business locations on a constant basis (

    • Benefits

  • Flexible working hours, incl. mobile work
  • 30 days of holiday time each year
  • 13.5 salaries a year
  • Regular training courses
  • Extensive company pension scheme
  • Payments towards an employee savings plan
  • Preventive healthcare, free beverages & fresh fruit and vegetables daily
  • Joint company events and activities
  • Interesting, diversified field of activity in an international working environment

    • Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

    Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.