Compliance 21 skills
ISO 13485, MDR, FDA, SOC 2, GDPR, EU AI Act, NIS2. 38 Python automation tools.
Capa Officer
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness...
Ccpa Cpra Privacy Expert
CCPA and CPRA privacy compliance automation. Audits organizations for California privacy law compliance, maps...
Dora Compliance Expert
DORA (EU 2022/2554) digital operational resilience compliance automation for financial entities. Assesses readiness...
Eu Ai Act Specialist
EU AI Act (Regulation EU 2024/1689) compliance specialist. Use when classifying AI systems by risk tier, assessing...
Fda Consultant Specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR...
Gdpr Dsgvo Expert
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks...
Information Security Manager Iso27001
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS...
Infrastructure Compliance Auditor
Cross-cutting infrastructure security audit skill that checks cloud infrastructure, DNS, TLS, endpoints, access...
Isms Audit Expert
Information Security Management System auditing for ISO 27001 compliance, security control assessment, and...
Iso42001 Ai Management
ISO 42001 AI Management System compliance automation. Assesses organizational readiness for AIMS certification,...
Mdr 745 Specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence,...
Nis2 Directive Specialist
NIS2 Directive (EU 2022/2555) compliance automation. Analyzes organizational scope, assesses compliance against all...
Nist Csf Specialist
NIST Cybersecurity Framework 2.0 implementation, assessment, and compliance management. Use for NIST cybersecurity...
Pci Dss Specialist
PCI DSS v4.0 payment card industry data security standard compliance, assessment, and implementation. Use for PCI...
Qms Audit Expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity...
Quality Documentation Manager
Document control system management for medical device QMS. Covers document numbering, version control, change...
Quality Manager Qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Use when conducting management...
Quality Manager Qms Iso13485
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS...
Regulatory Affairs Head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Use when developing regulatory strategy,...
Risk Management Specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk...
Soc2 Compliance Expert
SOC 2 Type I and Type II compliance management. Use when conducting SOC 2 readiness assessments, performing gap...