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Found 2 Skills
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
Analyzes clinical trial protocols and generates CDISC-compliant (SDTM/ADaM) data schemas. Use when designing data ingestion pipelines for clinical research or preparing regulatory submissions.