300 skills (repositories by borghei) · sorted by popularity
CCPA and CPRA California privacy compliance. Use for CCPA/CPRA readiness assessments, personal information data mapping, consumer rights handling, privacy policy review, opt-out mechanisms, and California privacy audits.
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Grant writing and proposal architecture: funder fit, proposal structure, budget design, and success-factor scoring. Use when writing a grant proposal, evaluating funder fit, auditing a draft for competitiveness, or planning a budget.
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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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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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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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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.
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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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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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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 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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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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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.
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ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
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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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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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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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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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Jira expert for project setup, workflow design, JQL queries, custom fields, automation rules, dashboards, and reporting. Use for Jira configuration, advanced search, board and dashboard creation, and technical Jira operations.
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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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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.
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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.
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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.
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Administer the Atlassian suite (Jira/Confluence): user provisioning, groups, SSO/SAML, permissions, security policies, marketplace apps, backups, and org-wide governance. Use for admin config, access management, and system optimization.
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Literature review for academic and R&D research: search strategy, source assessment, synthesis, and citation management. Use when conducting a systematic literature review, building a bibliography, or preparing a research-grounded report.
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