Job Summary

A healthcare research company has an open position for a Remote Companion Diagnostics Regulatory Affairs Director.

Core Responsibilities Include:

• Strategizing, planning and authoring regulatory plans/activities
• Authoring and providing critical input on FDA/Global Health Authority submissions
• Serving as a key member of the Regulatory team

Qualifications Include:

• B.S./B.A. in a science or related life science field
• 10 years experience in regulatory, development, clinical affairs, quality, or program management
• Experience with Companion Diagnostics (CDx) regulatory submissions for IDE, PMA and CE Mark
• Experience with Microsoft based applications and general knowledge of PC/Mac functions necessary
• Track record of leadership
• Demonstrated knowledge of regulations and procedures required for development of new medical devices