Compliance 27 skills
ISO 13485, MDR, FDA, SOC 2, GDPR, EU AI Act, NIS2. 51 Python automation tools.
Ai Act Readiness
EU AI Act readiness assessment and sprint playbook. Use when preparing for the Aug 2026 high-risk AI system...
Aims Audit
ISO 42001 AI Management System (AIMS) audit-prep playbook. Use when an ISO 42001 certification audit is scheduled...
Capa Officer
CAPA system management for medical device QMS, covering root cause analysis, corrective action planning, and...
Ccpa Cpra Privacy Expert
CCPA and CPRA California privacy compliance. Use for CCPA/CPRA readiness assessments, personal information data...
Compliance Readiness
Cross-framework compliance readiness orchestrator. Use when preparing for multi-framework certification (SOC 2 + ISO...
Dora Compliance Expert
DORA (EU 2022/2554) digital operational resilience compliance for financial entities, covering all 5 pillars. Use...
Eu Ai Act Specialist
EU AI Act (Regulation EU 2024/1689) compliance specialist. Use for AI system risk classification, provider/deployer...
Fda Consultant Specialist
FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820),...
Fda Qsr Audit Prep
FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA...
Gdpr Audit Prep
GDPR audit-prep playbook: sprint to prepare for a supervisory authority inquiry, DPA audit, or internal review. Use...
Gdpr Dsgvo Expert
GDPR and German DSGVO compliance. Use for GDPR compliance assessments, privacy audits, scanning codebases for...
Information Security Manager Iso27001
ISO 27001:2022 ISMS implementation and cybersecurity governance for HealthTech and MedTech. Use for ISMS design,...
Infrastructure Compliance Auditor
Cross-framework infrastructure security audit across cloud, network, and CI/CD. Use for infrastructure and cloud...
Isms Audit Expert
ISMS auditing for ISO 27001 compliance, control assessment, and certification support. Use for ISMS audit programs,...
Iso42001 Ai Management
ISO 42001 AI Management System (AIMS) compliance. Use for ISO 42001 readiness assessments, AI governance planning,...
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 for critical infrastructure entities, covering the 10 minimum security...
Nist Csf Specialist
NIST Cybersecurity Framework 2.0 implementation, assessment, and compliance management. Use for CSF 2.0 gap...
Pci Dss Specialist
PCI DSS v4.0 payment card data security compliance, assessment, and implementation. Use for PCI DSS scoping,...
Qms Audit Expert
ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity...
Quality Documentation Manager
Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11...
Quality Manager Qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality...
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. Use for regulatory strategy, FDA 510(k)/PMA/De Novo...
Risk Management Specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk...
Soc2 Audit Prep
SOC 2 audit-prep playbook: the 4/8/12-week sprint to audit-ready for a Type I or Type II observation. Use when the...
Soc2 Compliance Expert
SOC 2 Type I and Type II compliance management against the Trust Services Criteria. Use for SOC 2 readiness...