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regulatory-affairs-head

95 / 100 · Low risk

Fine to try. Some of what it can do is expected: a coding skill usually runs build and test commands.

By alirezarezvani/claude-skills (GitHub) · coding · 29,783 stars · scanned at commit 08cd8a9

Use for medical device market access strategy: FDA 510(k), De Novo or PMA packages, CE marking under MDR, pre-sub meetings, agency deficiency responses or multi-market plans. Analyzes pathways with regulatory_pathway_analyzer.py and tracks submissions with regulatory_tracker.py.

Works with any agent that supports SKILL.md skills.

What this skill can do

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'regulatory-affairs-head' ] || [ -L ~/.agents/skills/'regulatory-affairs-head' ]; then echo 'A skill folder named regulatory-affairs-head already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/alirezarezvani/claude-skills' "$d" && git -C "$d" checkout --quiet '08cd8a9fc86cc370e2c0d448e8171fbcfdbc5a30' -- 'ra-qm-team/skills/regulatory-affairs-head' && mkdir -p ~/.agents/skills && cp -R "$d"/'ra-qm-team/skills/regulatory-affairs-head' ~/.agents/skills/'regulatory-affairs-head' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'regulatory-affairs-head' ~/.claude/skills/'regulatory-affairs-head' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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