Regulatory Compliance Specialist

Gift of Life Michigan; Ann Arbor (MI); On-site; USD 60,000 - 80,000; Full time

Job summary

Gift of Life Michigan seeks a Regulatory Compliance Specialist who will ensure compliance with healthcare regulations and support internal quality initiatives. This role involves monitoring regulatory changes, developing policies, and liaising with external auditors. Candidates should possess strong organizational skills, attention to detail, and a bachelor's degree related to health policy.

Qualifications

• 3 years’ experience in compliance or regulatory affairs required.
• Experience in a healthcare organization or transplant center preferred.
• Knowledge of health regulations like FDA and HIPAA.

Responsibilities

• Monitor and communicate regulatory changes.
• Develop and maintain internal policies and procedures.
• Support internal audits and training programs.

Skills

Written and verbal fluency in English

Critical thinking

Problem-solving

Organizational skills

Attention to detail

Education

Bachelor’s degree in health policy or related field

Tools

Microsoft Office

Job description

Join to apply for the Regulatory Compliance Specialist role at Gift of Life Michigan

Join to apply for the Regulatory Compliance Specialist role at Gift of Life Michigan

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.

Description

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.
  
  

Qualifications

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Biotechnology Research

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