Regulatory & Quality Assurance Specialist

About the role

The Regulatory & Quality Assurance Specialist supports the U.S. DME by maintaining regulatory and compliance processes, documentation, and records in alignment with applicable federal, state, internal, and quality requirements. The role partners cross-functionally to support accreditation, audit readiness, and accurate compliance reporting under the direction of the Audit Manager and in collaboration with corporate partners.

Job responsibilities

• Manage transparency reporting requirements by tracking and reporting transfers of value to healthcare professionals (HCPs) and healthcare organizations (HCOs) in compliance with federal and state regulations.
• Ensure accuracy, completeness, and organization of reporting data and supporting documentation.
• Support ongoing maintenance and reconciliation of transparency data.
• Assist with the application & renewal process for DMEPOS accreditation through CMS-approved organizations.
• Support the collection of policies, procedures, and evidence of compliance to meet DMEPOS quality standards.
• Cover coordination with accrediting bodies and internal teams to schedule and prepare for site visits and inspections.
• Participate and support audits by being onsite to address auditor questions or provide documentation.
• Maintain up-to-date records of licenses, certifications, and compliance documentation.
• Prepare for Medicare audits by maintaining the Medicare binder and presenting key info to senior leadership.
• Assists with writing policies, standard operating procedures (SOPs), work instructions, and other required documentation in accordance with established quality requirements.
• Acts as the Document Control Specialist, partnering with internal departments to establish consistent and best practices for document control policies and procedures.
• Ensure documentation is organized, accessible, and audit-ready.
• Partner with Global Legal and Compliance teams to support compliance of the local Quality Management System (QMS) with applicable regulations, including FDA, HIPAA, Medicare/Medicaid, and state requirements.
• Aid in periodic reviews of policies, procedures, and controls to ensure alignment with current regulatory and contractual requirements.
• Support and maintain accurate reporting activities by collecting and organizing data related to controls, improvements, audit findings, complaints, and investigations.
• Gather, organize, and review documentation for CMS and other external insurance claim audits.
• Support the internal audit program including audit scheduling, conducting audits, preparing/reviewing audit reports, and managing audit files.
• Assist Audit Manager in determining actions sufficient to correct problems or effect change through Non-Conformance or CAPA investigations, as well as Change Control.
• Ensure all audit and investigation documentation includes appropriate objective evidence of compliance.
• Execute and track transactional compliance work (licenses, accreditation, reporting).
• Ensure tasks are completed accurately and within required timelines.
• Meet individual, departmental, and company goals.
• Perform other related duties as assigned by management.

Basic qualifications

• HS Diploma or equivalent
• 3-5 years of relevant business experience, preferably in health care related industry standards
• Working knowledge of US Quality System Regulations
• Demonstrated experience in project management, process improvement, and decision-making abilities

Prior to qualifications

• Bachelor’s Degree
• In-depth knowledge of the industry’s standards and regulations, including QMS
• Excellent knowledge of reporting procedures and record keeping
• Demonstrated experience in DMEPOS, CMS, accreditation preparation, implementation

Skills & Abilities

• Proven knowledge in MedTech or DME Quality System Management.
• Excellent data collection and analysis skills with a strong attention to detail.
• Strong time management, organizational, and prioritization skills.
• Able to manage multiple tasks, with tight deadlines, while maintaining accuracy.
• Able to work independently in a single-person function.
• Inquisitive mindset with sound judgment to question processes and decisions appropriately.
• Methodical and diligent with outstanding planning abilities.
• Integrates and demonstrates core values, integrity and accountability.
• Excellent verbal and written communication skills.
• Self-motivated, and ability to work with minimal supervision.
• Intermediate skill in MS Office (Word, Excel, PowerPoint, Outlook, Visio).
• Brightree, SAP and Salesforce experience preferred.