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Gift of Life Michigan · 6 hours ago

Regulatory Compliance Specialist

Ann Arbor, MI

Full-time

Onsite

Mid Level

3+ years exp

Gift of Life Michigan is dedicated to supporting a culture of compliance and continuous improvement. The Regulatory Compliance Specialist is responsible for ensuring adherence to federal, state, and accreditation regulations, while collaborating with various teams to implement policies and support quality assurance initiatives.

Health Care

Comp. & Benefits

Responsibilities

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

Qualification

Regulatory compliancePolicy analysisHealthcare regulationsQuality AssuranceMicrosoft OfficeCritical thinkingProblem-solvingOrganizational skillsCommunication skills

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

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