Regulatory Affairs Head
alirezarezvani/claude-skills/ra-qm-team/skills/regulatory-affairs-headby alirezarezvani19392f7a0826No license27K starsListed Oct 8, 2026Updated Oct 8, 2026Repository updated 5 weeks ago
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 plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
Only the file list is public. File contents are available once the skill is installed in a workspace.
| Path | Size | Type |
|---|---|---|
| references/eu-mdr-submission-guide.md | 3.2 KB | text/markdown |
| references/fda-submission-guide.md | 4.3 KB | text/markdown |
| references/global-regulatory-pathways.md | 9.6 KB | text/markdown |
| references/iso-regulatory-requirements.md | 13.8 KB | text/markdown |
| scripts/regulatory_pathway_analyzer.py | 22.5 KB | text/plain |
| scripts/regulatory_tracker.py | 8 KB | text/plain |
| SKILL.md | 19.7 KB | text/markdown |
Source and attribution
Source:alirezarezvani/claude-skillsinra-qm-team/skills/regulatory-affairs-headat commit19392f7
License: No license
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