Director, Quality & Regulatory Affairs

Job ID: 31155761Posted: Posted 8 Days AgoStart Date: 2026-07-23Location: United States - California - Livermore, United States of AmericaTime Type: Full timeAbbott 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 AbbottAt 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 ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar yearAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA 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 FortuneA 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 scientistsThe OpportunityAcelis 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 OnQuality 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 HandlingCorrective and Preventive Actions (CAPA)Recall ManagementSupplier Quality ManagementDocument ControlTraining and Compliance ProgramsEstablish 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 LicensingMedicare and Medicaid EnrollmentsThe Joint Commission AccreditationRegulatory Agency Reporting and ComplianceMonitor changing healthcare regulations and assess business impact.Serve as the primary point of contact for regulatory agencies, accreditation bodies, and external auditors.Ensure timely execution of licensing, accreditation, certification, and enrollment activities to support ACH operations nationwide.Accreditation & Patient Access:Lead organizational efforts related to maintaining and expanding The Joint Commission accreditation.Partner with cross-functional stakeholders to ensure compliance with accreditation and reimbursement requirements.Drive strategies that enhance patient access through effective regulatory and licensing management.Support advocacy and operational initiatives related to Medicaid, reimbursement, and healthcare access.Maintain effective governance processes that align quality and regulatory requirements with business objectives.Support strategic business initiatives, new service offerings, and market expansion activities.Metrics & Performance Management:Develop, maintain, and report key performance indicators (KPIs) related to quality systems, regulatory compliance, licensing, accreditation, and operational effectiveness.Present performance updates, compliance trends, and risk assessments to senior leadership.Drive accountability through measurable objectives and continuous improvement initiatives.People Leadership:Lead, coach, and develop a high-performing Quality Systems & Regulatory Affairs team.Create an engaging and inclusive culture focused on accountability, compliance, and customer service excellence.Attract, retain, and develop top talent while building organizational capability.Provide leadership, direction, and succession planning for the function.Required QualificationsBachelor's degree in Healthcare Administration, Business Administration, Quality, Regulatory Affairs, or a related field.12+ years of progressive experience in healthcare regulatory compliance, accreditation, licensing, quality systems, or related disciplines, including direct people leadership experience with demonstrated success developing and managing high-performing teams.Working knowledge of:Quality Management Systems (QMS)CAPA and Complaint ManagementMedicare and Medicaid regulationsState licensing requirementsAccreditation standards and audit readinessDemonstrated ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.Strong analytical, communication, and executive presentation skills.Preferred QualificationsMaster's degree (MBA, MHA, MSN, MPH, or related field).Professional certification such as:Certified Professional in Healthcare Quality (CPHQ)Regulatory Affairs Certification (RAC)Certified in Healthcare Compliance (CHC)5+ years of experience within a healthcare provider organization governed by CMS and The Joint Commission.Deep expertise in Medicare and Medicaid enrollment processes and state licensing requirements.Experience leading Joint Commission surveys and accreditation readiness programs.Advanced knowledge of quality system processes, including CAPA, complaint handling, supplier management, and document control.Experience operating within a large, matrixed healthcare or medical device organization.This job description reflects the current primary responsibilities of the role. Responsibilities, scope, and organizational relationships may be modified as needed to meet changing business requirements and organizational priorities.APPLY NOWLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobalThe base pay for this position is $172,000.00 – $344,000.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Operations QualityDIVISION:HF Heart FailureLOCATION:United States > Livermore : 6465 National DriveADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 25 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: