Individual skill

regulatory-affairs-head

Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.

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

Source commit 25bf86b89c6c1e63f433a5b65e8cfcb6cf0b7ad3

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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