Director, Quality & Regulatory Affairs

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. Youll 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 bachelors 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 80000 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 Youll Work On

Quality Systems Leadership:

• Lead the development implementation maintenance and continuous improvement of ACHs 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

• Bachelors 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

• Masters 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

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

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Director