Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

Quick Start

Claude Code

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

Codex CLI

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

Skills Overview

Skill

Folder

Focus

Regulatory Affairs Head

regulatory-affairs-head/

FDA/MDR strategy, submissions

Quality Manager (QMR)

quality-manager-qmr/

QMS governance, management review

Quality Manager (ISO 13485)

quality-manager-qms-iso13485/

QMS implementation, doc control

Risk Management Specialist

risk-management-specialist/

ISO 14971, FMEA, risk files

CAPA Officer

capa-officer/

Root cause analysis, corrective actions

Quality Documentation Manager

quality-documentation-manager/

Document control, 21 CFR Part 11

QMS Audit Expert

qms-audit-expert/

ISO 13485 internal audits

ISMS Audit Expert

isms-audit-expert/

ISO 27001 security audits

Information Security Manager

information-security-manager-iso27001/

ISMS implementation

MDR 745 Specialist

mdr-745-specialist/

EU MDR classification, CE marking

FDA Consultant

fda-consultant-specialist/

510(k), PMA, QSR compliance

GDPR/DSGVO Expert

gdpr-dsgvo-expert/

Privacy compliance, DPIA

Python Tools

17 scripts, all stdlib-only:

python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help

python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help

Rules

• Load only the specific skill SKILL.md you need

• Always verify compliance outputs against current regulations