Regulatory & Quality

18 skills in this domain

Install all: claude /plugin install ra-qm-skills

• CAPA Officer

  ---

  Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cau...

• EU AI Act Compliance Specialist

  ---

  Article-cited operational skill for Regulation (EU) 2024/1689. Three decisions, no executive AI strategy:

• FDA Consultant Specialist

  ---

  FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (Q...

• GDPR/DSGVO Expert

  ---

  Tools and guidance for EU General Data Protection Regulation (GDPR) and German Bundesdatenschutzgesetz (BDSG) complia...

• Information Security Manager - ISO 27001

  ---

  Implement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regula...

• ISMS Audit Expert

  ---

  Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and c...

• ISO/IEC 42001 AI Management System Specialist

  ---

  Internal-audit-grade operating skill for ISO/IEC 42001:2023. Three decisions, no executive AI strategy:

• MDR 2017/745 Specialist

  ---

  EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

• QMS Audit Expert

  ---

  ISO 13485 internal audit methodology for medical device quality management systems.

• Quality Documentation Manager

  ---

  Document control system design and management for ISO 13485-compliant quality management systems, including numbering...

• Senior Quality Manager Responsible Person (QMR)

  ---

  Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause...

• Quality Manager - QMS ISO 13485 Specialist

  ---

  ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device or...

• Regulatory Affairs & Quality Management Skills

  ---

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

• Head of Regulatory Affairs

  ---

  Regulatory strategy development, submission management, and global market access for medical device organizations.

• Risk Management Specialist

  ---

  ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

• SOC 2 Compliance

  ---

  SOC 2 Type I and Type II compliance preparation for SaaS companies. Covers Trust Service Criteria mapping, control ma...