Regulatory Compliance Specialist

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.

Research Compliance Services ( RCS) supports the Office of the Vice Chancellor for Research ( OVCR). RCS enables and protects UNC-Chapel Hill`s $1 billion research enterprise by ensuring adherence to applicable regulations, policies, and ethical standards. In alignment with the OVCR`s mission to grow and support research through strategic leadership, infrastructure development, and external engagement, our unit provides essential oversight and guidance to facilitate compliant research practices. By working collaboratively with researchers and administrative units, we help mitigate risk, promote integrity, and uphold the standards necessary to advance the University`s varied and interdisciplinary research portfolio.

The Temporary Regulatory Compliance Specialist will play a key role in supporting UNC's regulatory compliance initiatives, with a primary focus on FDA regulations and associated institutional policies. The role will include developing standard operating procedures (SOPs) for a cGMP audit program, assisting in planning and documentation for expanded clinical access to advanced technologies (e.g., HIFU machine), and supporting other regulatory and compliance-related special projects.

Key Responsibilities:

SOP Development & Audit Support
o Draft, edit, and implement SOPs for an FDA-compliant audit program aligned with Good Manufacturing Practices (cGMP).
o Collaborate with internal teams and subject matter experts to ensure SOPs align with regulatory standards and organizational practices.
o Support preparation for internal and external regulatory audits.

HIFU (High Frequency Ultrasound) Clinical Access Planning
o Contribute to the development of a regulatory and operational framework that facilitates UNC-H patient access to the HIFU machine located on the university campus.
o Research and document regulatory, operational, and contractual requirements to support patient access and safety.
o Coordinate with stakeholders across the university and health system to ensure adherence to FDA and institutional requirements.

Special Projects
o Provide compliance guidance and project support on regulatory initiatives as assigned.
o Assist with documentation, reporting, and implementation of new compliance programs.

Monitor and interpret evolving FDA, cGMP, and clinical research regulations to inform project activities and ensure alignment with current standards.

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.

* Bachelor's degree in life sciences, regulatory affairs, health administration, or a related field;
* 15+ years of experience in FDA regulatory compliance, cGMP environments, or clinical research compliance.
* Demonstrated experience conducting clinical research.
* Familiarity with clinical trial operations, advanced medical imaging technologies, or investigational device regulations a plus.
* Strong organizational, writing, and communication skills.
* Proven ability to work independently and manage multiple priorities in a fast-paced environment.

Advanced degree in life sciences, regulatory affairs, health administration or related field preferred.
Experience drafting SOPs and supporting regulatory audits strongly preferred.

This position is designated as a Campus Security Authority in accordance with the Clery Act. This position will be required to report Clery crimes to the Clery Compliance Manager and complete annual training about reporting responsibilities.

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.