REQUIREMENTS:

Must reside in the United States

Other Duties:

• Keeps abreast of evolving and state-of-the-art regulatory policies and procedures and best practices.
• Completes maintenance training and pursues professional development/continuing education opportunities.
• Fosters a culture of continuous improvement and accountability.
• Identifies opportunities for Third Party Review Program process improvements.
• Coordinates review logistics with the Project Manager to ensure Third Party Review determinations are promptly submitted to FDA’s Third Party Review staff

Accountability/Supervision:

• Manages and reviews the consultations produced by External Technical Experts that are selected by the Product Specialist as part of the review team.
• Works well both independently and as part of a multidisciplinary/cross-functional team.
• Receives general direction, guidance, and supervision from the Final Reviewer as needed.
• The Final Reviewer reviews all completed review work