Documents, operations, planning, and everyday systems.
skills to explore
PUBLIC SKILLS, ONE SEARCHABLE SHELFIndexed 25 Sep 2026 ↗
1–24 of 28 skills
/cs:ai-act-readiness <system> — EU AI Act 6-question forcing interrogation. Use during AI-system intake, before EU deployment, or during annual compliance refresh as Article 113 obligations phase in (2025-02-02 / 2025-08-02 / 2026-08-02 / 2027-08-02).
/cs:aims-audit <scope> — ISO/IEC 42001 AIMS internal-audit 6-question forcing interrogation.
Running, diagnosing, or designing internal business operations — process documentation, vendor SLAs, capacity planning, internal comms, SOP/runbook authoring, procurement spend.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics.
An ops leader (Director of CX, Head of Support, VP Ops, Head of BizOps, Head of IT ops, Head of Finance ops) is sizing ops capacity, building a headcount plan, modeling utilization risk, planning Q3 capacity or annual support capacity, or designing CS coverage — and needs Erlang-C queueing math, P90 demand sizing, shrinkage-adjusted FTE, manager-trigger thresholds, and a…
Compliance OS — meta-orchestrator that lets compliance teams CONFIGURE which frameworks apply, COMPUTE cross-framework control overlap, SIMULATE internal audits, and CONSOLIDATE evidence across multiple frameworks.
/cs:compliance-readiness <program> — Multi-framework compliance officer 6-question forcing interrogation of any compliance program.
EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 43 conformity assessment route (Module A internal control vs Module H full…
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity.
/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation.
/cs:gdpr-audit-prep <scope> — GDPR audit 6-question Article-cited forcing interrogation. Use before annual internal GDPR review, post-breach internal audit, DPA investigation readiness, or acquisition due diligence.
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests with Art. 12(3) one-month deadlines.
Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support.
/cs:iso13485-audit-prep <scope> — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused.
/cs:iso27001-audit-prep <scope> — ISO 27001 ISMS audit readiness 6-question forcing interrogation.
ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits.
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.
A BizOps lead, COO, or process-improvement owner needs to document an end-to-end business process (procurement, employee onboarding, incident handoff, customer-onboarding, claims adjudication) in BPMN-style notation, measure cycle times by stage, surface where work spends most of its time waiting vs. being worked, and quantify the gap between processing time and total…
Running an annual SaaS audit, doing category-level spend review, or rationalizing the supplier base — when the user needs a spend audit, spend categorization (UNSPSC-aligned with Pareto breakdown and industry profiles), purchasing-cycle analysis (bottleneck categories per Goldratt's Theory of Constraints), or risk-balanced supplier consolidation that refuses single-source…
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification.
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.
ISO 13485 Quality Management System implementation and maintenance for medical device organizations.
Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing).
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across…
Source-linked, not execution-tested. Check the publisher’s setup instructions and permissions before use.