Compliance Coordinator

Job Summary

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