Compliance Coordinator

To ensure rigorous adherence to regulatory frameworks, the full-time remote Compliance Coordinator will manage compliance operations, support inspection readiness, and maintain documentation while collaborating with cross-functional teams to uphold standards in a highly regulated environment. Key responsibilities Coordinate and track compliance initiatives, ensuring alignment with regulatory requirements and organizational priorities Maintain an organized compliance library and support controlled document management processes Assist in inspection readiness activities, including coordinating mock audits and tracking compliance metrics Required qualifications Working knowledge of 503A and 503B regulatory frameworks and related standards Experience in supporting compliance activities such as internal audits and documentation review Familiarity with leveraging technology, including AI tools, for regulatory research and compliance tasks Detail-oriented with a process-driven mindset for maintaining SOPs and compliance tracking tools Ability to assist in drafting regulatory responses and contributing to root cause analysis efforts