ניהול פרויקט רגולציה
Required:
. Degree in a related scientific discipline (e.g., medical, nursing,
public health, biology, statistics, etc.)
. Knowledge of FDA & CE regulations
. Experience in medical device regulatory affairs, including FDA and
CE submissions
. At least 5 years experience in biotechnology/medical device industry
. English mother tongue level
Preferred:
. Experience in clinical study management according to GCP
requirements
. Experience in implementing QA systems according to QSR and ISO 13485
standard
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