Regulatory & Quality Assurance Specialist

Regulatory & Quality Assurance Specialist | Atos Medical-US | New Berlin, WI | On-site

Join a growing company with a strong purpose!

Do you want to make a difference for people breathing, speaking and living with a neck stoma? At Atos Medical, our people are the strength and key to our on-going success. We create the best customer experience and thereby successful business through our 1300 skilled and engaged employees worldwide.

About Atos Medical

Atos Medical is a global leader in neck stoma care—dedicated to improving the lives of people living with laryngectomy and tracheostomy. With origins in Sweden and Germany, both our Laryngectomy and Tracheostomy brands bring decades of expertise and innovation in voice and respiratory care, offering trusted solutions such as the Provox® voice prosthesis and TRACOE tracheostomy products.

As part of the Coloplast Group, we operate in over 90 countries with a shared commitment to clinical excellence, patient support, and high-quality medical devices that help people breathe, speak, and live more comfortably.

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

• 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.

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.


• Meets individual, departmental, and company goals.


• Performs 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.


• Intermediate skill in MS Office (Word, Excel, PowerPoint, Outlook, Visio).


• Brightree, SAP and Salesforce experience preferred.

WE OFFER

Atos Medical is a global leader headquartered in Sweden, united by a shared purpose and strong values. Guided by our superpowers—patient-centric, dedication, agile, and the belief that you never walk alone—we support and empower our users, our colleagues, and our partners every day. We believe in working together, growing together, and treating everyone we interact with—patients, coworkers, health care professionals, and partners—with respect and integrity.

You will be part of an ambitious work environment in which teams work together to continuously grow and develop the business. You will have great opportunities to learn and develop, and you will be offered a competitive salary package and benefits.

TOTAL REWARDS

At Atos Medical, a Coloplast company, we value and reward the contributions of our employees. Our total rewards package supports your well-being, professional growth, and work-life balance. Here's what you can expect:

Health & Wellness: 

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  • 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
  
  
  
  

Financial Security: Competitive 401(k) with a dollar-for-dollar match up to 6% and immediate vesting, financial planning services, and corporate discounts.

State-of-the-art facility: Hybrid and onsite employees work from our state-of-the-art facility, thoughtfully designed with sit-stand desks, large monitors, and premium onsite amenities, including a gym and golf simulator.

Work-Life Balance: Flexible work options, Generous PTO plan, 10 paid holidays, and summer hours to help you recharge.

Professional Development: Ongoing learning and career growth opportunities through training, mentorship, and tuition reimbursement.

Community & Culture: Join a Top Workplace, as recognized by USA Today and the Milwaukee Journal Sentinel. We foster a supportive environment where everyone feels valued and included. Engage in team-building, volunteer events, and our 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 800-217-0025.

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business. 

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S

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