regulatory-affairs-head
🤖 AI Summary
This agent automates the preparation and review of FDA regulatory submissions (510(k), De Novo, PMA) for medical devices and drafts responses to agency inquiries. It also analyzes and recommends optimal regulatory pathways for new HealthTech and MedTech products.
How to Install
Claude Code:
git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git && cp claude-skills/.gemini/skills/regulatory-affairs-head ~/.claude/skills/regulatory-affairs-head -rSenior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts response
Details
| Category | AI/ML → prompt |
| Source | alirezarezvani/claude-skills |
| SKILL.md | View on GitHub → |
| Repo Stars | ★ 18.9K |
| Est. per Skill | 47 (shared across 394 skills from this repo) |
| Difficulty | Intermediate |
| Risk Level | Safe |
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