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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.
Reason about SaMD (Software as a Medical Device) regulatory compliance for FDA, EU MDR, and global submissions. Use when the user asks about IEC 62304 safety classification, ISO 14971 risk management, 21 CFR 820/QMSR quality system requirements, Design History File structure, 510(k)/De Novo/PMA pathway selection, SOUP/OTS assessment, verification and validation planning, cybersecurity for medical devices, PCCP for AI/ML devices, design reviews, traceability matrices, or post-market surveillance. Triggers include "SaMD", "medical device software", "IEC 62304", "ISO 14971", "ISO 13485", "21 CFR 820", "QMSR", "510(k)", "De Novo", "PMA", "design history file", "DHF", "software safety classification", "SOUP list", "risk management", "hazard analysis", "design review", "V&V protocol", "FDA submission", "EU MDR", "clinical evaluation", "PCCP", "predetermined change control", "GMLP", "cybersecurity premarket", "Part 11", "design controls", "design inputs", "design outputs", "traceability matrix", "post-market surveillance", "CAPA", "Class II device", "Class III device", "regulatory pathway", "predicate device", "substantial equivalence".