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Regulatory Affairs Specialist (w / m / d)

Regulatory Affairs Specialist (w / m / d)

NDI Europe GmbHRadolfzell, Baden-Württemberg, DE
Vor 30+ Tagen
Stellenbeschreibung

TASKS

Do you keep track of complex regulatory requirements and work in a structured and independent manner? Then we look forward to receiving your application! Your tasks :

  • Ensuring compliance with regulatory requirements in the area of material compliance (e.g. RoHS, REACH, PFAS) and processing corresponding customer inquiries
  • Maintenance and use of relevant databases for material declarations
  • Monitoring and implementation of normative requirements (MDR, FDA, ISO )
  • Support in quality management, especially in document management, training and CAPA processes
  • Review and approval of technical documents as well as support for projects and production inspections

PROFILE

  • Successfully completed technical or scientific studies or comparable training
  • Several years of experience in the field of regulatory affairs in medical technology, especially in the area of material compliance
  • Very good knowledge of the relevant standards and regulations (ISO , MDR, FDA) and knowledge of quality management are an advantage
  • Very good written and spoken German and English skills
  • Independent, structured and assertive personality with team spirit and strong communication skills
    • Jobalert für diese Suche erstellen

    Regulatory Specialist • Radolfzell, Baden-Württemberg, DE