The Compliance Coordinator is responsible for monitoring, interpreting, and implementing state-level regulatory requirements to ensure the organization maintains full compliance across all jurisdictions in which it operates.
Requirements
- Prepare, submit, and manage required state registration filings, renewals, and reports.
- Serve as a point of contact with state regulatory agencies, ensuring timely and accurate responses to inquiries.
- Support regulatory examinations, audits, and inspections, including documentation gathering and remediation follow-up.
- Maintain accurate records of regulatory correspondence, filings, and compliance documentation.
- Automate tracking of renewal cycles, deadlines, and state-specific requirements in SF360, ensuring accurate FDA Form 2579 submission and oversight.
- Collect, audit, and centrally archive all 2579 forms, submitting required copies to state radiation authorities within mandated timelines.
- Conduct ongoing compliance audits, maintain organized documentation, and develop dashboards, trackers, and reports to monitor regulatory status.
- Provide training and compliance guidance to vendors and engineers, ensuring adherence to federal and state reporting requirements and escalating issues as needed.
- Support the company’s import compliance program as needed by verifying proper equipment documentation, aligning import records with FDA/state data, and identifying discrepancies or risks.
- Maintains confidentiality and demonstrates professionalism in all interactions.