אחראי רגולציה - LEAD קליני
Radix Engineering Pvt. Ltd.
אחראי רגולציה – LEAD קליני
Regulatory Affairs Program Leadיקנעם עילית | היברידי
Radix Engineering מגייסת עבור חברה גלובלית מובילה בתחום המכשור הרפואיתחומי אחריות
פיתוח, הובלה וניהול של אסטרטגיות ומסלולים רגולטוריים עבור מכשור רפואי חדש ומוצרים משודרגים.- ובלת והכנת הגשות רגולטוריות מורכבות ל-FDA ולרשויות בינלאומיות, במטרה להבטיח אישורי שיווק גלובליים בזמן.
- בטחת התאמת תהליכי פיתוח המוצר והמחקרים הקליניים ל
דרישות
הרגולטוריות וליעדים העסקיים.
תואר ראשון (ומעלה) בתחום מדעי או הנדסי רלוונטי.
- יסיון של 6–8 שנים לפחות בתחום הרגולציה בתעשיית המכשור הרפואי (לא פארמה).
- יסיון מוכח בניהול מסלולים רגולטוריים מורכבים ובהגשות בינלאומיות.
נכונות לנסיעות לחו”ל בהיקף של עד 10% מהזמן.
#J-18808-Ljbffr Radix Engineering Pvt. Ltd.Vacancy posted 2 days ago
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