Associate Director, Radiology Regulatory Affairs

University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 69,000 - 93,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Retirement plans

Time away from work

Wellness programs

Job summary

The University of Pennsylvania in Philadelphia seeks an Associate Director, Radiology IND/IDE Support Office to lead daily operations, oversee IND/IDE studies, and serve as the liaison with the FDA to ensure regulatory compliance and GCP adherence.

You will supervise a regulatory staff of fewer than 10, manage risk-based monitoring, and collaborate across Radiology, Perelman School of Medicine, and OCR to support investigators and study integrity.

Qualifications

• Bachelor's degree in a scientific or related discipline and 7-10 years of monitoring experience.
• Master's degree preferred with 5-6 years of relevant experience.
• Experience supporting FDA-regulated clinical research, including IND/IDE studies.
• Demonstrated knowledge of FDA regulations, guidance, and compliance requirements.

Responsibilities

• Lead the daily operations of the Radiology IND/IDE Support Office, overseeing INDs/IDEs and liaising with the FDA to ensure FDA regulations, GCP, and SOPs are followed.
• Develop and implement risk-based monitoring plans, review protocols/CRFs to protect human subjects and ensure data integrity and regulatory compliance.
• Oversee study-specific monitoring visits and prepare monitoring reports under OCR Compliance, supervising staff (<10).
• Provide strategic oversight of FDA regulatory, safety reporting, and compliance activities for investigator-initiated studies.

Skills

Regulatory affairs

FDA regulations

Clinical research monitoring

Staff leadership

GCP

Communication

Education

Bachelor's degree in science

Master's degree preferred

Job description

The University of Pennsylvania in Philadelphia seeks an Associate Director, Radiology IND/IDE Support Office to lead daily operations, oversee IND/IDE studies, and serve as the liaison with the FDA to ensure regulatory compliance and GCP adherence.

You will supervise a regulatory staff of fewer than 10, manage risk-based monitoring, and collaborate across Radiology, Perelman School of Medicine, and OCR to support investigators and study integrity.