תיאור התפקיד
This is a full-time on-site role located in Jerusalem for a Regulatory Affairs Specialist. The RA Specialist will report directly to the VP QA / RA, and will be responsible for ensuring that all Alpha Tau Medical products are in compliance with established internal policies, international and local regulatory requirements, and industry best practices. The RA Specialist will also communicate with regulatory authorities, prepare regulatory submissions, and identify and address regulatory issues on an ongoing basis
דרישות התפקיד
Minimum of 3-5 years of experience in Regulatory Affairs in the medical device or pharmaceutical industry
B.S. Degree in a scientific or engineering field, higher education is preferred
Demonstrated knowledge of global regulations and guidelines for medical devices
Experience with the preparation of successful regulatory submissions such as IDE, PMA, 510(k), MDR, and CE Marking
Proven ability to work on cross-functional teams and to balance competing priorities
Excellent communication and interpersonal skills
Proficient in English, and additional languages are preferred but not required
