Regulatory Compliance Specialist

Gift of Life Michigan-posted 5 days ago
$75,000 - $81,250/Yr
Full-time
Ann Arbor, MI
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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.

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