Skills regulatory-affairs-head
📦

regulatory-affairs-head

Content revision r1 Safe ⚙️ External commands📁 Filesystem access

Lead Medical Device Regulatory Strategy

Medical device teams face complex submission paths, quality requirements, and market access timelines. This skill helps Claude, Codex, and Claude Code guide regulatory planning with structured MedTech expertise.

Supports: Claude Codex Code(CC)
🥇 83 Gold

Install with my Agent

Copy this request to your Agent. It includes the canonical Skill page and manifest.

Agent request
Review the Skillstore skill "regulatory-affairs-head" from https://skillstore.io/skills/alirezarezvani-regulatory-affairs-head.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-regulatory-affairs-head/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.

Your Agent should still show its plan and request any confirmation required by the security policy.

Agent-readable resources

Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.

Markdown detail GET /skills/alirezarezvani-regulatory-affairs-head.md Signed manifest GET /api/skills/alirezarezvani-regulatory-affairs-head/manifest Signed lockfile GET /api/skills/alirezarezvani-regulatory-affairs-head/lockfile

Test it

Using "regulatory-affairs-head". Plan a 510(k) submission for a connected blood glucose monitor.

Expected outcome:

  • Recommended starting path: Class II 510(k) with predicate analysis.
  • Key evidence: analytical performance, clinical accuracy, software documentation, cybersecurity assessment, and labeling.
  • Core owners: regulatory, quality, clinical, engineering, software, and marketing.
  • Main risks: predicate mismatch, incomplete software documentation, and delayed performance testing.

Using "regulatory-affairs-head". What should we prepare before contacting a Notified Body?

Expected outcome:

  • Confirm device classification and conformity assessment route.
  • Prepare a technical documentation gap analysis against EU MDR Annex II and Annex III.
  • Define clinical evidence strategy, PMS plan, PMCF needs, and UDI readiness.
  • Create an internal timeline that accounts for Notified Body capacity and review cycles.

Using "regulatory-affairs-head". Create a regulatory risk review for an upcoming submission.

Expected outcome:

  • Market access risk: review delays from incomplete evidence packages.
  • Operational risk: unclear ownership across quality, clinical, and engineering teams.
  • Compliance risk: outdated guidance or insufficient post-market planning.
  • Mitigation: pre-submission engagement, responsibility matrix, and recurring regulatory intelligence checks.

Security Audit

Safe
v7 • 7/9/2026 Open versioned report

The static findings are false positives caused by regulatory terms, markdown code fences, file names in documentation, and normal local JSON persistence. I found no evidence of malicious command execution, network reconnaissance, system reconnaissance, prompt injection, or data exfiltration intent in the reviewed files.

6
Files scanned
849
Lines analyzed
0
Review items
0
False positives ignored

Risk Factors

⚙️ External commands (14)
evaluation.json:102-108 SKILL.md:54-66 SKILL.md:66-112 SKILL.md:112-113 SKILL.md:113-114 SKILL.md:114-117 SKILL.md:117-118 SKILL.md:118-119 SKILL.md:119-120 SKILL.md:120-121 SKILL.md:121-124 SKILL.md:124-125 SKILL.md:125-126 SKILL.md:126-127
📁 Filesystem access (1)
scripts/regulatory_tracker.py:92
No confirmed security findings were detected by the latest completed static and semantic audit. This does not prove the skill has no side effects.
Audited by: claude View Audit History →
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Open versioned report
Security Assessment

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Academic citations (APA · BibTeX · CFF)

APA citation

alirezarezvani. (2026). regulatory-affairs-head security audit report (audit version 7) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-regulatory-affairs-head/audits/7

BibTeX citation

@techreport{alirezarezvani-alirezarezvani-regulatory-affairs-head-2026, author = {alirezarezvani}, title = {regulatory-affairs-head security audit report (audit version 7)}, institution = {Skillstore}, year = {2026}, number = {7}, url = {https://skillstore.io/skills/alirezarezvani-regulatory-affairs-head/audits/7}, note = {Author version unspecified} }

CITATION.cff

cff-version: 1.2.0 message: "If you use this Skill, cite its author and this versioned security audit report." title: "regulatory-affairs-head security audit report (audit version 7)" version: "unspecified" type: report authors: - name: "alirezarezvani" date-released: "2026-07-09" url: "https://skillstore.io/skills/alirezarezvani-regulatory-affairs-head/audits/7" identifiers: - type: other value: "skillstore:alirezarezvani-regulatory-affairs-head:audit:7" description: "Skillstore immutable audit report identifier"

Compare variants

2 installable variants

Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.

Why this variant is first

Higher Skillstore usage
alirezarezvani Recommended Current

alirezarezvani-regulatory-affairs-head

Skillstore Score 83
Evidence Confidence High
Skillstore usage 17
Updated

2026-08-21

davila7

davila7-regulatory-affairs-head

Skillstore Score 83
Evidence Confidence High
Skillstore usage 11
Updated

2026-08-21

Skillstore Score

Why this score Evidence Confidence: High
77
Architecture
85
Maintainability
87
Content
70
Community
83
Spec Compliance

What You Can Build

Define a market access path

Map FDA, EU MDR, and global pathway options before product development decisions are locked.

Prepare a submission plan

Build checklists, timelines, and responsibility matrices for 510(k), PMA, De Novo, or CE submissions.

Coordinate compliance readiness

Align quality, clinical, engineering, and leadership teams around documentation and audit expectations.

Try These Prompts

Choose a regulatory pathway 
Help me choose a regulatory pathway for a medical device. The device is [device type], the intended use is [intended use], and the target markets are [markets].
Plan an FDA submission 
Create an FDA submission plan for [device name]. Include pathway assumptions, required evidence, likely review steps, timeline risks, and cross-functional owners.
Assess EU MDR readiness 
Review our EU MDR readiness for a [device class] device. Focus on technical documentation, clinical evidence, QMS needs, UDI, and Notified Body engagement.
Build a regulatory leadership plan 
Act as Head of Regulatory Affairs for our MedTech portfolio. Create a 90-day plan covering submissions, regulatory risks, team cadence, escalation paths, and executive reporting.

Best Practices

  • Start regulatory planning before major design decisions are finalized.
  • Validate assumptions against current official guidance and qualified experts.
  • Assign clear owners for evidence, quality records, labeling, and authority responses.

Avoid

  • Treating regulatory affairs as a final documentation step after development ends.
  • Using outdated pathway assumptions without checking current FDA or EU MDR guidance.
  • Relying on generic templates without adapting them to device class and intended use.

Frequently Asked Questions

What regulatory areas does this skill cover?
It covers FDA pathways, EU MDR planning, ISO-related readiness, global market access, and regulatory team coordination.
Can it replace a regulatory consultant or lawyer?
No. It supports planning and analysis, but qualified professionals must review high-risk decisions and official submissions.
Does it submit documents to FDA or EU authorities?
No. It helps prepare plans, checklists, and communication strategy, but it does not access regulator systems.
Which users benefit most from this skill?
Founders, regulatory affairs managers, quality leaders, and product teams working on HealthTech or MedTech products benefit most.
Does it include operational tracking?
Yes. It includes a simple local Python tracker for submission status, deadlines, overdue items, and status reports.
How should users handle sensitive submission data?
Users should store sensitive data only in approved systems and avoid placing confidential records in unprotected local files.

Developer Details

License

MIT

Skillstore revision

r1

Version notice

The author did not declare a version.

Repository

https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/regulatory-affairs-head

Ref

7db9b9f06e0ab79c575b58bc48c4d8dc9849f424

Maintenance freshness

7/18/2026

Usage

13 downloads · 213 views

File structure

📁 assets/

📄 example_asset.txt

📁 references/

📄 eu-mdr-submission-guide.md

📄 fda-submission-guide.md

📁 scripts/

📄 regulatory_tracker.py

📄 evaluation.json

📄 SKILL.md