Algorithms Validation Specialist

Job Title: Algorithms Validation SpecialistLocation: San Francisco (Hybrid )Employment Type: ContractJob SummaryWe 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 ResponsibilitiesValidate ML algorithms used in clinical imaging systems in alignment with CSV standardsDesign, develop, and execute validation protocols for imaging-based ML modelsEnsure compliance with Good Clinical Practices (GCP), FDA, and other regulatory requirementsMaintain accurate and audit-ready validation documentationCollaborate with data scientists, software engineers, and CROs for seamless integration of validated models into clinical workflowsSupport audits and regulatory submissions by providing comprehensive validation reportsDrive validation initiatives and coordinate with cross-functional stakeholdersRequired QualificationsStrong understanding of clinical imaging workflowsHands-on experience in ML algorithm validation within regulated environmentsExperience with CSV (Computer System Validation) processesKnowledge of regulatory frameworks such as GCP and FDA guidelinesExcellent communication and stakeholder management skillsPreferred QualificationsExperience with ML algorithms in Radiology and Digital PathologyPrior experience working with pharmaceutical or biotech organizationsKnowledge of SaMD (Software as a Medical Device) complianceExperience validating imaging software and ML models used in diagnosticsKey SkillsMachine Learning ValidationClinical Imaging SystemsRegulatory Compliance (GCP, FDA)Computer System Validation (CSV)Documentation & Audit SupportCross-functional CollaborationNavya MarripudiIT Lead Recruiter | S4 AnalyticseMail: navya@s4analytix.comD: +1 (551) 300-0477 Ext.108