Regulatory Compliance Manager, Cardiology

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.

Regulatory Operations

• 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.

Compliance & Quality Assurance

• 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.

Collaboration & Communication

• 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.

Training & Policy Development

• 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.

MINIMUM REQUIREMENTS

Education: Bachelor's degree

Experience: At least eight years of relevant experience.

Licensure: Subject matter licensure may be required.

Preferred Qualifications:

• 10+ years of experience in regulatory compliance and IRB

PHYSICAL DEMANDS

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

Salary will be commensurate with education and experience. This is an exempt-level, benefited position. Learn more about UVA benefits. This is a restricted position, which is dependent on funding and is contingent upon funding availability.

This position is based in Charlottesville, VA, and is eligible for a hybrid schedule of several days on campus per week, with additional on-site presence as needed, in accordance with UVA's remote work guidelines. To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Background checks and pre-employment health screenings will be conducted on all new hires prior to employment.

This position will not consider candidates who require immigration sponsorship at this time.

HOW TO APPLY

Please apply online, by searching for requisition number R0076922. Complete an application with the following documents:

• Resume
• Cover Letter

Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.

Internal applicants: Apply through your Workday profile by searching "Find Jobs."

Reference checks will be completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, please contact Jeremy Brofft, Senior Recruiter at xmf9ad@virginia.edu.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Click here to read more about UVA's commitment to non-discrimination and equal opportunity employment.