Regulatory Affairs Head

This brings senior regulatory affairs expertise for HealthTech and MedTech companies navigating FDA, EU MDR, and global submission pathways. You get strategic planning frameworks for choosing between De Novo, 510(k), PMA routes, submission workflow management from pre-submission through post-market surveillance, and cross-functional coordination protocols with actual handoff requirements. It includes regulatory decision frameworks, risk assessment templates, and references practical tools like submission trackers and compliance checkers. Most useful when you're planning market access strategy, managing regulatory submissions, or coordinating between engineering, quality, and regulatory teams. The KPI tracking and escalation procedures suggest real operational experience rather than generic compliance advice.

Install to Claude Code

npx -y skills add davila7/claude-code-templates --skill regulatory-affairs-head --agent claude-code