Individual skill

regulatory-affairs-head

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.

ra-qm-team/skills/regulatory-affairs-head/SKILL.md

Source commit 8f082544116fc0d014188e521ca40304cdfc86b0

What was checked

Matches the observed repository HEAD

Yes

Scanner rules are current

Yes

Repository scan complete

No

Skill scan complete

No

Observed behavior

Network or broad shell

Last checked

Nov 10, 2026

These are observations at the recorded commit, not a guarantee of safety. Review the source before running it.

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