Regulatory Compliance Specialist
- Monitor, interpret, and communicate regulatory changes from agencies such as CMS, FDA, OPTN, HRSA, OSHA, as well as accreditation standards from AATB.
- Develop, update, and maintain internal policies, procedures, and guidelines for designated clinical and administrative areas within the organization to ensure alignment with legal, regulatory, and accreditation requirements.
- Collaborate with clinical, administrative, and operational teams to support policy implementation and risk mitigation.
- Serve as a resource for policy interpretation and compliance inquiries.
- Complete compliance forms and reports for regulatory agencies.
- Support internal audits and quality management system activities, including the investigations of incidents. Assist in the implementation, development, and tracking corrective action / preventive action (CAPA) plans and quality improvement initiatives.
- Assist with staff training programs to reinforce organ and tissue donation processes and regulatory awareness.
- Serve as a liaison with external auditors during regulatory or accreditation inspections.
- Perform other duties as assigned.
- Bachelor’s degree in health policy, healthcare administration, public health, business administration, or a related field plus 3 years’ experience in compliance, regulatory affairs, or policy analysis and/or combination or education and experience.
- Prior experience in a healthcare organization, transplant center, or organ/tissue procurement organization.
- Familiarity with health regulations and standards (e.g., FDA 21 CFR Part 1271, HIPAA, OSHA, AATB, AOPO, OPTN).
- Strong writing and research skills; ability to interpret complex regulations and translate them into actional policies.
- Knowledge of Quality Assurance and Performance Improvement (QAPI) frameworks.
- Familiarity with compliance or quality management systems.
- Written and verbal fluency in English.
- Ability to exercise initiative, critical thinking, and problem-solving.
- Proficiency with Microsoft Office programs, including Outlook and Teams and other technology systems used in business operations.
- Strong organizational skills and ability to manage multiple and competing priorities.
- Excellent attention to detail and organizational skills.
- Excellent verbal and written communication.
- Knowledge of quality and quality improvement methodologies.
- Demonstrate the competencies of Professional, Determined and Compassionate.
- Maintain a motivated and positive attitude.
- Support an inclusive work environment.
- Successfully collaborate and work as a member of an interdisciplinary team.
- Actively seek improvements.
- Always maintain a safe working environment and use of Universal Precautions.
- Maintain appropriate level of confidentiality in all areas dealing with sensitive, protected, and confidential information.
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