regulatory-affairs-head
by alirezarezvani (GitHub) in alirezarezvani/claude-skills
What it does
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 u
Quoted from the skill's SKILL.md under its MIT license.
Install
git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git /tmp/claude-skills mkdir -p ~/.claude/skills/ cp -r /tmp/claude-skills/ra-qm-team/skills/regulatory-affairs-head ~/.claude/skills/regulatory-affairs-head
The command copies the skill from the author's repo. SkillTrove does not host it.
Files
- SKILL.md
- references/eu-mdr-submission-guide.md
- references/fda-submission-guide.md
- references/global-regulatory-pathways.md
- references/iso-regulatory-requirements.md
- scripts/regulatory_pathway_analyzer.py
- scripts/regulatory_tracker.py
Source: https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/regulatory-affairs-head. Checked 2026-10-13.
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