Regulatory & Quality Assurance Specialist

Regulatory & Quality Assurance Specialist Location: New Berlin, US Job Family: Quality Assurance Country/Region: United States Regulatory & Quality Assurance Specialist | Atos Medical-US | New Berlin, WI | On-site Join a growing company with a strong purpose! We are seeking a Regulatory & Quality Assurance Specialist to join our team!

SUMMARY

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

Transparency Reporting 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. Accreditation and CMS Site Visit Management 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. Coordinate 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. Documentation & Training Assist with writing policies, standard operating procedures (SOPs), work instructions, and other required documentation in accordance with established quality requirements. Act 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. Quality Management System (QMS) Administration & Compliance 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. Assist 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. Audits & 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. Administrative & General Responsibilities 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

PREFERRED 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. Ability 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. Brightree, SAP and Salesforce experience preferred.

WE OFFER

We offer a comprehensive benefits package that supports well‑being, professional growth, and work‑life balance: Comprehensive medical, dental, and vision coverage for you and your family. Access to company‑sponsored wellness programs and mental health resources. Paid leave for qualifying events, and generous parental leave for both birthing and non‑birthing parents. Health Savings Account (HSA) with employer contributions. Competitive 401(k) with a dollar‑for‑dollar match up to 6% and immediate vesting, financial planning services, and corporate discounts. Hybrid and onsite employees work from a state‑of‑the‑art facility, thoughtfully designed with sit‑stand desks, large monitors, and premium onsite amenities, including a gym and golf simulator. Flexible work options, generous PTO plan, 10 paid holidays, and summer hours to help you recharge. Ongoing learning and career growth opportunities through training, mentorship, and tuition reimbursement. Engagement in team‑building, volunteer events, and sustainability initiatives. Atos Medical, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. To request reasonable accommodation to participate in the job application, please contact View phone number on click.appcast.io. #J-18808-Ljbffr Coloplast