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Found 3 Skills
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw.