regulatory-affairs-head

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.

Quality

90%

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Quality

Content

81%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

A well-structured, highly actionable regulatory skill with numbered workflows, validation checkpoints, and concrete templates/scripts. It is let down slightly by conciseness (reference-style padding inlined in SKILL.md) and a minor progressive-disclosure gap where one bundled script is unreferenced.

Suggestions

Move the KPI, Regulatory Monitoring Sources, and Common FDA Deficiencies tables into a reference file (e.g., references/regulatory-operations.md) and link to them from SKILL.md to reduce inlined padding.

Reference regulatory_pathway_analyzer.py in the Scripts table alongside regulatory_tracker.py so the bundled tool is discoverable.

Tighten the Regulatory Escalation Criteria and Documentation Efficiency Strategy tables to the essential rows, or relocate them to a reference file.

Dimension	Reasoning	Score
Conciseness	Mostly efficient and free of concept over-explanation, but several inline tables (Common FDA Deficiencies, Regulatory Monitoring Sources with frequencies, KPIs, Regulatory Escalation Criteria) are reference padding that competes with context and could be tightened or moved to a reference file.	3 / 5
Actionability	Provides concrete, copy-ready artifacts: 510(k)/PMA submission checklists, a Substantial Equivalence comparison table, a fill-in Regulatory Strategy template, GSPR checklist rows, and a real regulatory_tracker.py script with example invocation and output.	5 / 5
Workflow Clarity	Each multi-step workflow is numbered and closes with an explicit 'Validation' checkpoint (e.g., '8. Validation: Submission accepted; MDUFA date received; tracking system updated'), and complex processes carry itemized checklists.	5 / 5
Progressive Disclosure	Body links to one-level-deep references that exist (fda/eu-mdr/global-regulatory-pathways/iso guides) and a scripts table, but a present bundle file (regulatory_pathway_analyzer.py) is never referenced from the body, and some content that could live in references is inlined.	4 / 5
	Total	17 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong, third-person description that pairs concrete capabilities with an explicit 'Use when' trigger clause covering the natural phrasing users would say. It is comprehensive, well-scoped, and carries minimal conflict risk with other skills.

Dimension	Reasoning	Score
Specificity	Lists six concrete actions ('Prepares FDA 510(k), De Novo, and PMA submission packages', 'drafts responses to FDA deficiency letters', 'develops CE marking technical documentation under EU MDR 2017/745', 'coordinates multi-market approval strategies'), giving comprehensive coverage of the domain rather than vague abstractions.	5 / 5
Completeness	Explicitly answers both 'what' (the enumerated actions) and 'when' via a concrete '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...' trigger clause.	5 / 5
Trigger Term Quality	Includes natural phrases users actually say — 'FDA submissions', '510(k)', 'PMA approval processes', 'CE marking', 'regulatory strategy documents', 'agency queries', 'compliance documentation', 'medical device market access' — with synonyms and variations well covered.	5 / 5
Distinctiveness Conflict Risk	Occupies a clear niche (medical-device regulatory affairs) with distinct triggers (510(k), PMA, CE marking, EU MDR, Notified Body) that are unlikely to fire for unrelated skills.	5 / 5
	Total	20 / 20 Passed

Validation

87%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 14 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning
relative_links	Relative link issues: 4 suspicious	Warning

	Total	14 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: ra-qm-team/skills/regulatory-affairs-head/SKILL.md
Commit: 19392f7

Reviewed: 7 minutes ago

Table of Contents

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