Regulatory Affairs Director

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