Specialist, Regulatory & Quality

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 115000 colleagues serve people in more than 160 countries.

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 Abbotts 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 Youll 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

• Bachelors 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

• Bachelors 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.

Learn 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.

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The base pay for this position is

$61300.00 $122700.00

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

Operations Quality

HF Heart Failure

United States > Lake Mary : 1101 Greenwood Boulevard

Standard

Yes 10 % of the Time

No

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

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