Regulatory Affairs & Quality Management Skills Collection

Complete suite of 12 world-class expert skills for HealthTech and MedTech organizations covering regulatory compliance, quality management, risk management, security, and audit excellence.

---

📚 Table of Contents

• Installation
• Overview
• Skills Architecture
• Complete Skills Catalog
• Quick Start Guide
• Team Structure Recommendations
• Regulatory Frameworks Covered
• Common Workflows
• Integration Points
• Success Metrics

---

⚡ Installation

Quick Install (Recommended)

Install all RA/QM skills with one command:

# Install all RA/QM skills to all supported agents
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team

# Install to Claude Code only
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team --agent claude

# Install to Cursor only
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team --agent cursor

Install Individual Skills

# Strategic Leadership
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/regulatory-affairs-head
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/quality-manager-qmr

# Quality Systems
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/quality-manager-qms-iso13485
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/capa-officer
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/quality-documentation-manager

# Risk & Security
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/risk-management-specialist
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/information-security-manager-iso27001

# Regulatory Specialists
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/mdr-745-specialist
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/fda-consultant-specialist

# Audit & Compliance
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/qms-audit-expert
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/isms-audit-expert
npx ai-agent-skills install alirezarezvani/claude-skills/ra-qm-team/gdpr-dsgvo-expert

Supported Agents: Claude Code, Cursor, VS Code, Copilot, Goose, Amp, Codex

Complete Installation Guide: See ../INSTALLATION.md for detailed instructions, troubleshooting, and manual installation.

---

🎯 Overview

This comprehensive skills collection provides world-class regulatory affairs and quality management capabilities for HealthTech and MedTech organizations navigating complex global regulatory landscapes.

What's Included:

• 12 expert-level skills across 5 specialized layers
• 36 Python automation tools for compliance tracking and reporting
• 36 comprehensive reference guides with regulatory frameworks
• Complete coverage of EU MDR, FDA, ISO 13485, ISO 27001, GDPR compliance

Key Benefits:

• 🚀 Accelerated Market Access - Optimized regulatory pathways and submission efficiency
• 🛡️ Reduced Compliance Risk - Systematic compliance across all jurisdictions
• ⭐ Quality Excellence - World-class QMS and continuous improvement capabilities
• 💰 Cost Optimization - Automated processes and efficient resource utilization

---

🏗️ Skills Architecture

The 12 skills are organized across 5 strategic layers:

Strategic Leadership Layer (2 Skills)

1. Senior Regulatory Affairs Manager (Head of RA)
2. Senior Quality Manager Responsible Person (QMR)

Core Quality Management Layer (3 Skills)

3. Senior Quality Manager - QMS ISO 13485 Specialist
4. Senior CAPA Officer
5. Senior Quality Documentation Manager

Risk & Security Management Layer (2 Skills)

6. Senior Risk Management Specialist (ISO 14971)
7. Senior Information Security Manager (ISO 27001/27002)

Regulatory Specialization Layer (2 Skills)

8. Senior MDR 2017/745 Specialist
9. Senior FDA Consultant and Specialist

Audit & Compliance Layer (3 Skills)

10. Senior QMS Audit Expert
11. Senior ISMS Audit Expert
12. Senior GDPR/DSGVO Expert

---

📦 Complete Skills Catalog

1. Senior Regulatory Affairs Manager (Head of Regulatory Affairs)

Package: regulatory-affairs-head.zip

Purpose: Strategic regulatory leadership and cross-functional coordination for market access.

Key Capabilities:

• Strategic regulatory planning and pathway analysis
• EU MDR and FDA submission management
• Global regulatory intelligence and coordination
• Cross-functional team leadership
• Regulatory risk assessment and mitigation

Python Tools:

• regulatory_pathway_analyzer.py - Analyze optimal regulatory routes
• submission_timeline_tracker.py - Track submission progress and milestones
• regulatory_intelligence_monitor.py - Monitor global regulatory changes

Reference Guides:

• eu-mdr-submission-guide.md - Complete EU MDR submission process
• fda-submission-guide.md - FDA pathway guidance (510k, PMA, De Novo)
• global-regulatory-pathways.md - International regulatory frameworks

Use When:

• Planning regulatory strategy for new products
• Managing major regulatory submissions
• Coordinating cross-functional regulatory activities
• Assessing regulatory risks and opportunities

---

2. Senior Quality Manager Responsible Person (QMR)

Package: quality-manager-qmr.zip

Purpose: Overall quality system responsibility and regulatory compliance oversight.

Key Capabilities:

• Management accountability for quality system
• Strategic quality leadership and planning
• Multi-jurisdictional compliance coordination
• Quality system effectiveness monitoring
• Regulatory authority liaison

Python Tools:

• qms_effectiveness_monitor.py - Monitor QMS performance metrics
• compliance_dashboard_generator.py - Generate compliance status reports
• management_review_analyzer.py - Analyze management review data

Reference Guides:

• qmr-responsibilities.md - Complete QMR role definition
• quality-leadership-framework.md - Strategic quality management
• management-review-guide.md - Effective management reviews

Use When:

• Providing overall quality system oversight
• Coordinating regulatory compliance activities
• Leading management reviews
• Interfacing with regulatory authorities

---

3. Senior Quality Manager - QMS ISO 13485 Specialist

Package: quality-manager-qms-iso13485.zip

Purpose: ISO 13485 QMS implementation, maintenance, and optimization.

Key Capabilities:

• ISO 13485 QMS implementation and certification
• Design controls and document control systems
• Management review and continual improvement
• Internal audit program management
• Supplier quality management

Python Tools:

• qms_compliance_checker.py - Check ISO 13485 compliance status
• design_control_tracker.py - Track design control activities
• document_control_system.py - Manage controlled documents

Reference Guides:

• iso-13485-implementation.md - Complete implementation guide
• design-controls-handbook.md - Design control best practices
• internal-audit-program.md - Audit planning and execution

Use When:

• Implementing or maintaining ISO 13485 QMS
• Managing design control processes
• Conducting internal audits
• Preparing for certification audits

---

4. Senior CAPA Officer

Package: capa-officer.zip

Purpose: Corrective and preventive action management within QMS.

Key Capabilities:

• CAPA investigation and management
• Root cause analysis (5 Whys, Fishbone, Fault Tree)
• Systematic problem-solving methodologies
• Effectiveness verification and trend analysis
• Continuous improvement program management

Python Tools:

• capa_tracker.py - Track CAPA status and effectiveness
• root_cause_analyzer.py - Facilitate root cause analysis
• trend_analysis_tool.py - Analyze quality trends and patterns

Reference Guides:

• capa-process-guide.md - Complete CAPA process
• root-cause-analysis-methods.md - RCA methodologies
• effectiveness-verification.md - CAPA effectiveness assessment

Use When:

• Managing non-conformities and deviations
• Conducting root cause investigations
• Implementing corrective actions
• Verifying CAPA effectiveness

---

5. Senior Quality Documentation Manager

Package: quality-documentation-manager.zip

Purpose: Documentation control and review of all norms and appendices.

Key Capabilities:

• Regulatory documentation management
• Document control system operation
• Change control and version management
• Multi-jurisdictional document compliance
• Technical file and DHF maintenance

Python Tools:

• document_version_control.py - Manage document versions
• technical_file_builder.py - Build regulatory technical files
• document_compliance_checker.py - Verify document compliance

Reference Guides:

• document-control-procedures.md - Document control best practices
• technical-file-requirements.md - Technical documentation requirements
• change-control-process.md - Change management procedures

Use When:

• Managing controlled documentation
• Building technical files for submissions
• Implementing document control systems
• Coordinating multi-jurisdictional documentation

---

6. Senior Risk Management Specialist

Package: risk-management-specialist.zip

Purpose: ISO 14971 risk management throughout product lifecycle.

Key Capabilities:

• ISO 14971 risk management implementation
• Risk analysis and evaluation methodologies
• Risk control implementation and verification
• Post-production information analysis
• Benefit-risk assessment

Python Tools:

• `risk_register_manage