ISO 27001:2022 ISMS implementation and cybersecurity governance for HealthTech and MedTech. Use for ISMS design, risk assessment per Clause 6.1.2, Annex A controls, ISO 27001 certification, security audits, and incident response.
日本語の概要は準備中です。原文の説明を表示しています。
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
日本語の概要は準備中です。原文の説明を表示しています。
Turn meeting notes into an accountable register — extract decisions, actions and open questions, flag ownerless items, track follow-through. Use when commitments get dropped or a recurring meeting decides nothing.
日本語の概要は準備中です。原文の説明を表示しています。
FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.
日本語の概要は準備中です。原文の説明を表示しています。
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Use for Annex VIII classification, GSPR, clinical evaluation, EUDAMED, and UDI.
日本語の概要は準備中です。原文の説明を表示しています。
Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
日本語の概要は準備中です。原文の説明を表示しています。
UX research and design toolkit covering persona generation, journey mapping, usability testing, and research synthesis. Use for user research, persona creation, journey mapping, or design validation.
日本語の概要は準備中です。原文の説明を表示しています。
Confluence expert for spaces, knowledge bases, documentation, page layouts, macros, templates, and Jira-Confluence integration. Use for documentation strategy, space architecture, content organization, and collaborative knowledge management.
日本語の概要は準備中です。原文の説明を表示しています。
Data-driven Scrum Master for sprint health scoring, Monte Carlo velocity forecasting, retrospective analysis, capacity planning, and Tuckman team coaching. Use when facilitating sprint planning, diagnosing velocity, or running retrospectives.
日本語の概要は準備中です。原文の説明を表示しています。
DORA (EU 2022/2554) digital operational resilience compliance for financial entities, covering all 5 pillars. Use for DORA readiness assessments, ICT risk management, incident classification, and third-party ICT oversight.
日本語の概要は準備中です。原文の説明を表示しています。
Cross-framework infrastructure security audit across cloud, network, and CI/CD. Use for infrastructure and cloud security audits, security posture assessment, and validating technical controls for SOC 2, ISO 27001, and NIST CSF.
日本語の概要は準備中です。原文の説明を表示しています。
ISO 42001 AI Management System (AIMS) compliance. Use for ISO 42001 readiness assessments, AI governance planning, AI impact assessments, Annex A control validation, responsible AI implementation, and AIMS certification preparation.
日本語の概要は準備中です。原文の説明を表示しています。
NIST Cybersecurity Framework 2.0 implementation, assessment, and compliance management. Use for CSF 2.0 gap analysis, cybersecurity risk management, maturity assessment, CSF profiles, and cross-framework compliance mapping.
日本語の概要は準備中です。原文の説明を表示しています。
PCI DSS v4.0 payment card data security compliance, assessment, and implementation. Use for PCI DSS scoping, cardholder data environment (CDE) security, SAQ and ROC preparation, QSA engagement, tokenization, and merchant compliance.
日本語の概要は準備中です。原文の説明を表示しています。
CAPA system management for medical device QMS, covering root cause analysis, corrective action planning, and effectiveness verification. Use for CAPA investigations, 5-Why and fishbone analysis, and corrective action tracking.
日本語の概要は準備中です。原文の説明を表示しています。
UI design system toolkit covering design tokens, component documentation, responsive calculations, and developer handoff. Use for creating design systems, maintaining visual consistency, or facilitating design-dev handoff.
日本語の概要は準備中です。原文の説明を表示しています。
Expert agile coaching: framework selection, maturity assessment, retrospective facilitation, transformation roadmaps. Use when selecting an agile framework, coaching teams, facilitating retrospectives, or designing a transformation.
日本語の概要は準備中です。原文の説明を表示しています。
Create, modify, and govern reusable Jira and Confluence templates, blueprints, and standardized content structures. Use for org-wide templates, custom blueprints, page layouts, and automated content generation.
日本語の概要は準備中です。原文の説明を表示しています。
Notion expert for product management workflows. Use for database design for PRDs/OKRs/Roadmaps/Decisions, property and view design, page architecture, Notion REST API, and sync with Jira, Linear, and GitHub.
日本語の概要は準備中です。原文の説明を表示しています。
Productboard expert for workspace setup, Insight-to-Feature triage, Driver scoring, Releases, Roadmap views, and REST API automation. Use for Productboard administration, prioritization workflows, and programmatic API operations.
日本語の概要は準備中です。原文の説明を表示しています。
Senior PM for enterprise software and SaaS — portfolio management, quantitative risk analysis, prioritization, and executive reporting. Use for portfolio health reviews, board-ready status reports, and multi-project risk/capacity analysis.
日本語の概要は準備中です。原文の説明を表示しています。
Data-driven sprint retrospectives from git history — velocity, cycle/lead time, contributor insights, and churn hotspots. Use to run a retrospective, analyze team velocity or throughput, or generate a retro report from commit history.
日本語の概要は準備中です。原文の説明を表示しています。
ISMS auditing for ISO 27001 compliance, control assessment, and certification support. Use for ISMS audit programs, internal/external ISO 27001 audits, ISO 27002 Annex A control testing, and Stage 1/Stage 2 certification audits.
日本語の概要は準備中です。原文の説明を表示しています。
Clinical study operations — protocol structure, endpoint selection, eligibility design, sample-size and power planning, site feasibility, and documentation readiness. Use when planning, auditing, or costing a study.
日本語の概要は準備中です。原文の説明を表示しています。