Regulatory compliance manager vs irb compliance coordinator

Differences between regulatory compliance manager and irb compliance coordinator duties and responsibilities

Regulatory compliance manager example responsibilities.

• Lead the efforts managing quality systems to meet ISO 13485 and 11137 certification.
• Develop and manage GxP training programs.
• Manage and upload all documentation of the investigations into a HIPAA portal.
• Lead creation of enterprise data breach response policy and HIPAA audit readiness plan.
• Manage the quality system/ audit program in compliance to FDA, ISO requirements, corporate and division policies and procedures.
• Manage GxP inspections by domestic and international regulatory agencies.
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Irb compliance coordinator example responsibilities.

• Organize and lead study file audits to ensure FDA inspection readiness.
• Collect, manage and analyze preliminary data using SPSS statistical software.
• Produce reports of detail FDA panel meeting minutes in conformance with regulatory standards.
• Maintain HIPAA documents to protect the data collect and analyze during the research.
• Modify procedures, forms and processes directly relate to the updated Medicaid requirements annually.
• Register agency physicians and nurse practitioners in CAQH, Medicaid and Medicare systems to ensure compliance with regulatory requirements.
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