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 student debt program and FreeU 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.
• 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 Qualifications

• Bachelor'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.
• Experience working within a healthcare provider environment subject to CMS and regulatory oversight.
• Working knowledge of:
  • Quality Management Systems (QMS)
  • CAPA and Complaint Management
  • Medicare and Medicaid regulations
  • State licensing requirements
  • Accreditation standards and audit readiness
• Demonstrated ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
• Strong analytical, communication, and executive presentation skills.

Preferred Qualifications

• Master'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.

The base pay for this position is

$172,000.00 – $344,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure

LOCATION:

United States > Livermore : 6465 National Drive

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT 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: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf