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Algorithms Validation Specialist

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Job Title: Algorithms Validation Specialist
Location: San Francisco (Hybrid )
Employment Type: Contract
Job Summary: We are seeking an experienced Algorithms Validation Specialist to support Computer System Validation (CSV) activities for machine learning (ML) algorithms used in clinical imaging systems. The role involves validating algorithms developed by data scientists and ensuring compliance with regulatory standards such as GCP and FDA guidelines.
Key Responsibilities:
  • Validate ML algorithms used in clinical imaging systems in alignment with CSV standards
  • Design, develop, and execute validation protocols for imaging-based ML models
  • Ensure compliance with Good Clinical Practices (GCP), FDA, and other regulatory requirements
  • Maintain accurate and audit-ready validation documentation
  • Collaborate with data scientists, software engineers, and CROs for seamless integration of validated models into clinical workflows
  • Support audits and regulatory submissions by providing comprehensive validation reports
  • Drive validation initiatives and coordinate with cross-functional stakeholders
Required Qualifications:
  • Strong understanding of clinical imaging workflows
  • Hands-on experience in ML algorithm validation within regulated environments
  • Experience with CSV (Computer System Validation) processes
  • Knowledge of regulatory frameworks such as GCP and FDA guidelines
  • Excellent communication and stakeholder management skills
Preferred Qualifications:
  • Experience with ML algorithms in Radiology and Digital Pathology
  • Prior experience working with pharmaceutical or biotech organizations
  • Knowledge of SaMD (Software as a Medical Device) compliance
  • Experience validating imaging software and ML models used in diagnostics
Key Skills:
  • Machine Learning Validation
  • Clinical Imaging Systems
  • Regulatory Compliance (GCP, FDA)
  • Computer System Validation (CSV)
  • Documentation & Audit Support
  • Cross-functional Collaboration
  • Navya MarripudiIT Lead Recruiter | S4 Analyticse
  • Mail: navya@s4analytix.comD: +1 (551) 300-0477 Ext.108