Regulatory Affairs Director

תל אביב |
7 שנים ומעלה |
משרה מלאה
| לפני 22 שעות
תיאור משרה

Director / Sr. RA
Provide strategic regulatory input to early- stage projects in the field of medical device
Support FDA and MDD / MDR regulatory submissions of class II and class III medical devices,
including submissions for first-in-human studies
Develop and review of design documents
Support rest- of- world regulatory submissions
Required Education / Skills:
B.Sc. or above in Engineering / Life Sciences
English – mother tongue level
Proven knowledge of applicable regulations and product lifecycle processes
Proficient in regulatory and technical writing
Strong execution, written and verbal communication
Willingness to travel abroad

דרישות התפקיד

• 10+ years of experience in RA positions in the medical device industry
• Experience in international / global companies –advantage
• Experience in pre-clinical / clinical studies –advantage