Medical Records Validation Consultant

Job Summary

Seeking a part-time Medical Records Validation Consultant, this remote role will focus on hands-on testing and compliance validation of medical records management applications, ensuring adherence to regulatory standards such as HIPAA and FDA requirements.

Key Responsibilities

• Perform hands-on functional testing of medical records management and electronic records applications
• Execute compliance validation activities related to HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641
• Develop and execute test plans, test cases, validation scripts, and compliance documentation

Required Qualifications

• Experience testing or validating medical records systems and electronic document management systems
• Hands-on experience with software testing and validation in regulated healthcare environments
• Strong understanding of HIPAA Privacy and Security Rules and FDA 21 CFR Part 11
• Experience developing and executing functional and compliance test cases
• Ability to analyze regulatory requirements and translate them into testable validation criteria