Director, Quality & Regulatory Affairs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year - An excellent retirement savings plan with high employer contribution - Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists **The Opportunity** Acelis Connected Health (ACH) operates accredited Durable Medical Equipment (DME) and Independent Diagnostic Testing Facility (IDTF) businesses across all 50 states, supporting more than 80,000 patients through innovative connected healthcare solutions. The Director, Quality Systems & Regulatory is a key leadership role responsible for developing and executing strategies that maintain and expand patient access while ensuring compliance with The Joint Commission accreditation standards, state licensing requirements, CMS regulations, and Abbott corporate quality standards. This leader will oversee Quality Systems and Regulatory Affairs activities across ACH, driving operational excellence, regulatory compliance, inspection readiness, and continuous improvement. The role requires close partnership with Operations, Revenue Cycle Management, Finance, Commercial, Legal, Clinical Services, and the Office of Ethics & Compliance to ensure sustainable, compliant growth across all lines of business. As a member of the ACH Leadership Team, the Director will serve as a trusted advisor to the DVP/GM, providing strategic leadership and guidance on quality, accreditation, and licensing matters that directly impact patient access. **What You’ll Work On** *Quality Systems Leadership:* - Lead the development, implementation, maintenance, and continuous improvement of ACH's Quality Management System (QMS). - Ensure adherence to Abbott quality standards, regulatory requirements, and industry best practices. - Oversee all core quality system processes, including: - Complaint Handling - Corrective and Preventive Actions (CAPA) - Recall Management - Supplier Quality Management - Document Control - Training and Compliance Programs - Establish governance processes to monitor quality system effectiveness and drive continuous improvement. - Ensure inspection and audit readiness across all ACH operations. *Regulatory Affairs & Compliance:* - Lead regulatory strategies and activities that support patient access, operational compliance, and business growth. - Oversee regulatory programs including: - State Licensing - Medicare and Medicaid Enrollments - The Joint Commission Accreditation - Regulatory Agency Reporting and Compliance - Monitor changing healthcare regulations and assess business impact. - Serve as the primary point of contact for regulatory agencies, accreditation bodies, and external auditors. - E…