Regulatory compliance director vs irb compliance coordinator

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

Regulatory compliance director example responsibilities.

• Manage successful remediation plan of aseptic suite sterility failure/shutdown and FDA communications.
• Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
• Edit and revise all existing quality system policies to meet new regulations and changes make by FDA and other regulatory bodies.
• Develop, manage and implement program governance and structure to ensure major programs are strategically align with organizational objectives.
• Provide leadership to strengthen internal control environment and maintain SOX compliance.
• Develop effective relationships with control owners, besides educating them on SOX requirements.
Show more

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.
Show more