Specialist, Regulatory & Quality

About this role

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 your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity This position works out of our Lake Mary, Florida office within Abbott's Heart Failure Division and Acelis Connected Health business. The Regulatory and Quality Specialist serves as a key member of the Regulatory and Quality team, supporting regulatory compliance activities, accreditation documentation, state licensing, and audit preparation across the organization. Approximately 70% of the role focuses on healthcare regulatory compliance and accreditation, while 30% supports internal quality initiatives and continuous improvement efforts.

What You’ll Work On Regulatory (70%) • Support Joint Commission accreditation oversight, survey readiness, documentation reviews, corrective actions, and performance improvement initiatives. • Leads onsite activities, communications and strategic planning related to maintaining Joint Commission accreditation • Maintain and obtain state healthcare licenses, including durable medical equipment (DME) and other required healthcare licenses. • Directly correspond with State Licensing Agencies on licensing matters, including licensing deficiencies, renewal requirements, state disclosures, and amended filings • Monitor federal and state regulatory requirements and assess organizational impact. • Support CMS, Medicare (DMEPOS & IDTF), Medicaid, and related regulatory compliance activities. • Participate in regulatory audits, inspections, submissions, and responses to regulatory agencies. • Support regulatory and quality system training and education throughout the organization. • Contributes and participates in regulatory compliance assessments and gap analysis. • Research, draft, review, and maintain policies, procedures, and regulatory documentation. • Assist with regulatory and accreditation projects. • Maintains positive and cooperative communications and collaboration with all levels of employees and regulatory agencies.

Quality Support (30%) • Assist with the site Documentation System and the QA Work Order systems. • Support the quality system in assuring that all QA documents meet established divisional, corporate and regulatory standards, and that these documents are an efficient, effective system for both their use and Quality Assurance. • Help to conduct QA needs assessments and gap analysis. • Assist with ongoing evaluation and implementation of continuous improvement in relation to the quality system. • Support internal quality management and quality system activities. • Assist with quality audit readiness, internal audits, and corrective action tracking. • Partner with Quality leadership on process improvement initiatives. • Support quality metric development, monitoring, and reporting. • Assists with quality system projects.

Required Qualifications • Bachelor’s Degree or relevant education and experience. • 3-4 years of healthcare regulatory, accreditation, compliance, quality, or healthcare operations experience. • Experience supporting healthcare regulatory programs, accreditation readiness, licensure activities, and/or quality management systems. • Strong project coordination, documentation management, organizational, and communication skills. • Ability to work independently while collaborating effectively across multiple functions. • Strong attention to detail and commitment to quality and compliance. • Adheres to all Company HIPAA compliance regulations, business and professional ethics, and confidentiality and privacy regulations as outlined in the Employee Handbook.

Preferred Qualifications • Bachelor’s degree in healthcare administration, public health, public policy, business administration, or a related field. • 5-6 years of healthcare regulatory, accreditation, compliance, quality, or healthcare operations experience • The Joint Commission (TJC) accreditation experience (e.g., site survey, evidence of standards compliance (ESC), intracycle monitoring, SAFER Matrix, etc.) • Multi-state licensure experience (e.g., Board of Pharmacy, Department of Public Health, Department of Health, FL Agency for Health Care Administration (AHCA), etc.). • Experience or familiarity with quality frameworks or methodologies (e.g., NAHQ, SPO, PDSA, FMEA, DMAIC, etc.) • Experience with policy management, document control, and/or training Systems • Professional certifications such as CHC, CPHQ, CJCP, CAPM, or PMP or any other related credentials.

Physical Requirements • Must be able to work sitting down for extended periods of time. • Must be able to work with computers and multiple computer screens for extended periods of time.

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