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Pulmotree Medical
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Pulmotree Medical rekrutiert für Positionen:

Regulatory Affairs Manager

Handel

  • Rechtswesen
  • Rechtswesen

Anforderung

  • A Diploma or Master degree in a relevant subject and/or suitable experience in a regulatory role
  • Excellent knowledge of MDR, FDA requirements, with experience in supporting regulatory submissions
  • Extensive knowledge of combination product requirements to support i.e. New Drug Applications
  • Regulatory requirements for medical devices, medical software, and combination products
  • Experienced in risk management according to ISO 14971
  • Proven track record of preparing and managing successful quality audits and inspections
  • Very good communication skills both in German and English language
  • Please take into account that the place of work is Munich and a permanent work permit is required