RA Specialist

Company Description

Alpha Tau Medical focuses on research, development, and commercialization of Alpha DaRT (Diffusing Alpha-Emitters Radiation Therapy) for the treatment of various solid cancer tumors. The company is running multipool clinical trials all over the world. and growing rapidly. As such we look for an amazing RA specialist to join our team.

Role Description

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.

Qualifications

• 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