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Pulmotree Medical rekrutiert für Positionen:
Regulatory Affairs Manager
Regulatory Affairs Manager
Electrical engineer
Software Engineer
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
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