Regulatory & Quality Assurance Specialist (DME/CMS Compliance)

About the role

Our client is a well-established global healthcare company focused on designing and manufacturing specialized medical devices for airway management, speech rehabilitation, and respiratory care.

Responsibilities

• Manage regulatory compliance documentation and maintain audit-ready records.
• Support DMEPOS accreditation applications, renewals, and CMS site visits.
• Cook up and prepare for CMS, accreditation, and external audits.
• Maintain Quality Management System (QMS) documentation, SOPs, policies, and document control.
• Aid with CAPA, non-conformance investigations, change controls, and internal audits.
• Support transparency reporting and regulatory reporting requirements.
• Partner with Legal, Compliance, and cross-functional teams to ensure compliance with FDA, HIPAA, Medicare/Medicaid, and state regulations.

Requirements

• 3–5 years of Regulatory Affairs, Quality Assurance, or Compliance experience in the healthcare industry.
• Experience with DMEPOS, CMS (Medicare/Medicaid), healthcare audits, accreditation, or regulatory compliance.
• Working knowledge of Quality Management Systems (QMS) and U.S. healthcare regulations.
• Experience supporting audits, documentation, CAPA, SOPs, and compliance reporting.
• Strong organizational, analytical, and communication skills.
• Proficiency with Microsoft Office; Brightree, SAP, and Salesforce are a plus.
• Bachelor's degree preferred (High School Diploma/GED with relevant experience considered).

Qualifications

• Preferred experience includes Durable Medical Equipment (DME) industry experience.
• CMS or Medicare/Medicaid audit preparation experience.
• Accreditation readiness and site visit coordination experience.
• Process improvement and project management experience.