Regulatory Compliance Specialist

Summary

In alignment with Gift of Life Michigan’s core purpose and core values, the Regulatory Compliance Specialist collaborates with Gift of Life personnel to support a culture of compliance and continuous improvement. The Regulatory Compliance Specialist monitors, analyzes, and ensures compliance with federal, state, accreditation and other third-party regulations and standards, as well as Gift of Life policies and procedures. The Regulatory Compliance Specialist supports Quality Assurance department initiatives, compliance adherence and regulatory reporting for the organization.

Duties & Responsibilities

The following job duties and responsibilities are stated in broad terms and not intended to be inclusive.  Those in bold are essential duties of the position:

• 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.

Education and/or Experience

Required

• 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.

Preferred

• Knowledge of Quality Assurance and Performance Improvement (QAPI) frameworks.
• Familiarity with compliance or quality management systems.

Knowledge, Skills, and Abilities (KSA)

• 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. 

Organizational Culture Expectations

• 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.