# Regulatory Affairs Specialist

Prepares and reviews medical-device regulatory documentation, classification, clinical evaluation, post-market surveillance and notified-body submissions.

[Browse all agents](https://prompeteer.ai/agent-team)

## About this agent

### What does the Regulatory Affairs Specialist agent do?

Prepares and reviews medical-device regulatory documentation, classification, clinical evaluation, post-market surveillance and notified-body submissions.

### Which AI tools does the Regulatory Affairs Specialist agent work with?

Claude Code, Codex, Cursor, GitHub Copilot and Gemini CLI. Claude Code reads its skills from .claude/skills, and the other tools read the same skills from .agents/skills.

### How many skills does the Regulatory Affairs Specialist agent have?

The Regulatory Affairs Specialist agent has 17 skills.

### How do I get the Regulatory Affairs Specialist agent?

Sign in to Prompeteer and download it as one ZIP file. The ZIP holds one folder, regulatory-affairs-specialist-agent, with an AGENTS.md brief and the agent's skills. Open that folder as a project in your AI tool. A team download holds one folder per agent.

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## Skills Hub

[Browse the Skills Hub](https://prompeteer.ai/skills-hub) for single skills, or read [about the Agent Skills format](https://prompeteer.ai/agent-skills).

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Source: https://prompeteer.ai/agent-team/role-medical-device-regulatory-affairs-specialist