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regulatory-affairs-head

80 / 100 · Low risk

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

By anubhavg-icpl/vibe (GitHub) · coding · 13 stars · scanned at commit d51e7ac

Senior 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 responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to p…

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=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/anubhavg-icpl/vibe' "$d" && git -C "$d" checkout --quiet 'd51e7ac9a34111cd2e63daed83c2198f91570050' -- 'skills/rezvani-regulatory-affairs-head' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills/rezvani-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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