regulatory-affairs-head

I checked out your regulatory-affairs-head skill and noticed you're building something that bridges the gap between technical implementation and compliance requirements—that's a tough problem space that most skills don't even attempt. The 86 score feels right; there's solid foundational work here, but I'm curious how you're handling the inherent tension between keeping compliance guidance accessible and technically precise.

Links:

• GitHub
• Your agentic skill in the SkillzWave marketplace

The TL;DR

You're at 86/100, solid B territory. This is based on Anthropic's skill best practices rubric. Your Writing Style is your strongest area (9/10)—the voice is consistent and objective throughout. The weakest pull is Spec Compliance (12/15), mainly because your description could use more trigger phrases to help discovery.

What's Working Well

• Progressive disclosure structure is clean — You've properly delegated detailed guidance to reference files (eu-mdr-submission-guide.md, fda-submission-guide.md) while keeping SKILL.md as an overview. That's the right move for a complex domain.

• Strong trigger terms for discoverability — Your description nails specific regulatory workflows: "regulatory strategy," "submission planning," "risk assessment." These will actually help the right people find this skill.

• Practical decision framework — The "Regulatory Decision Framework" with numbered steps (1. Impact Assessment → 2. Pathway Selection → 3. Timeline Planning) gives users a clear entry point. That structure works.

• Comprehensive pathway coverage — Addressing both FDA and EU MDR submissions shows you understand the scope. That's not trivial.

The Big One

You're referencing files that don't exist — This is the heavyweight is...