Regulatory Compliance Manager, Cardiology

The Rector & Visitors Of The University Of Virginia • Charlottesville, VA

96d • Remote

About The Position

The Regulatory Compliance manager is responsible for managing the regulatory operations supporting cardiovascular research at the University of Virginia. This role oversees the day-to-day work of professional-level staff and ensures compliance with all institutional, federal, and sponsor regulations governing human subjects research. With both strategic and tactical oversight, the coordinator plays a key role in supporting high-quality, ethical cardiovascular research that advances patient care and scientific knowledge. The majority of time is spent overseeing clinical trial regulations, managing workflow, and ensuring that regulatory operations meet departmental goals and compliance standards.

Requirements

• Bachelor's degree
• At least eight years of relevant experience.
• Subject matter licensure may be required.

Nice To Haves

• 10+ years of experience in regulatory compliance and IRB

Responsibilities

• Oversee preparation and submission of IRB applications, amendments, safety reports, and continuing reviews.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, and institutional policies throughout the study lifecycle.
• Review and maintain regulatory documents and Trial Master Files (TMF/eTMF) for audit readiness.
• Serve as the institutional point of contact for IND/IDE support, where applicable.
• Develop, implement, and monitor internal regulatory compliance processes.
• Support audit preparation and response to IRB, sponsor, and regulatory inspections.
• Analyze compliance trends and lead the development of action plans for process improvement.
• Act as liaison between investigators, sponsors, CROs, IRB, and institutional regulatory offices.
• Collaborate with other departments (legal, clinical operations, data management) to ensure cross-functional alignment.
• Present updates and metrics to department leadership and other stakeholders.
• Provide regulatory guidance and training to staff, investigators, and research teams.
• Participate in development and revision of standard operating procedures (SOPs).
• Stay current with changes in regulatory requirements and advise stakeholders accordingly.

Benefits

• Salary will be commensurate with education and experience.
• This is an exempt-level, benefited position.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Educational Services
• Education Level: Bachelor's degree