> regulatory-affairs-head
../../../ra-qm-team/regulatory-affairs-head/SKILL.md
curl "https://skillshub.wtf/alirezarezvani/claude-skills/regulatory-affairs-head?format=md"../../../ra-qm-team/regulatory-affairs-head/SKILL.md
> related_skills --same-repo
> quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
> qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
> mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
> isms-audit-expert
Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use when the user mentions ISO 27001, ISMS audit, Annex A controls, Statement of Applicability (SOA), gap analysis, nonconformity management, internal audit, surveillance audit, or security certification preparation. Helps review control implementation evidence, document audit findings, classify nonconformities, generate risk-based audit plans,