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.
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Structured intelligence dossiers on companies, people, markets, or domains, with source triangulation and fact/inference discipline. Use when preparing a deal-prep dossier, executive briefing, or due-diligence overview.
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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.
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GDPR and German DSGVO compliance. Use for GDPR compliance assessments, privacy audits, scanning codebases for privacy risks, DPIA generation, data protection planning, and data subject rights management.
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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.
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ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity classification, CAPA verification, external audit preparation, or audit program management.
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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.
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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.
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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.
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Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
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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.
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Sales execution across pipeline, discovery, demos, negotiation, and closing. Use when qualifying opportunities, running MEDDIC discovery, building account plans, handling objections, structuring proposals, or forecasting pipeline.
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EU AI Act (Regulation EU 2024/1689) compliance specialist. Use for AI system risk classification, provider/deployer obligations, GPAI model compliance, conformity assessments, bias and fairness testing, and AI governance programs.
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Translate product specs (PRDs, user stories) into a ship-ready repo plan: ticket decomposition, branch strategy, and PR sequencing. Use when breaking a PRD into tickets or designing the branch/PR sequence.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance.
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