[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6DRWF8RS04FS99DCCR72FWC":3,"skill-same:01M6DRWF8RS04FS99DCCR72FWC":116},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":16,"categories":17,"keywords":37,"publishedAt":58,"linkOnly":59,"markdownContent":60,"markdownBody":61,"frontMatter":62,"refName":71,"commitSha":72,"skillDirectory":73,"forksCount":74,"repositoryHtmlUrl":75,"repositoryHomepageUrl":6,"ownerHtmlUrl":76,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":77,"install":78,"resources":91},"01M6DRWF8RS04FS99DCCR72FWC","cmo-advisor",null,"Marketing leadership for scaling companies. Brand positioning, growth model design, marketing budget allocation, and marketing org design. Use when designing brand strategy, selecting growth models (PLG vs sales-led vs community-led), allocating marketing budgets, building marketing teams, or when user mentions CMO, brand strategy, growth model, CAC, LTV, channel mix, or marketing ROI.","zhangzhang-111-i\u002Fclaude-skills111","zhangzhang-111-i","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F251344927?v=4","01M6DRBP4NCM1ZCHTT0FW0SQHD","lixiying","01M6DRBPAMFDJSGQ69XPK9KM9J",3,"MIT","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002FSKILL.md",[18,23,26,31,34],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":24,"categoryName":25,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000019","营销推广",{"categoryNo":27,"categoryName":28,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000032","设计师","PROFESSION","适用职业",{"categoryNo":32,"categoryName":33,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000035","市场营销",{"categoryNo":35,"categoryName":36,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000040","财务",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"cmo","cmo advisor","advisor","use","growth model","scaling","leadership","positioning","frameworks","community","models","design","growth","sales","strategy","brand","model","Budget","teams","roi","2026-11-10 10:12:30",false,"---\nname: \"cmo-advisor\"\ndescription: \"Marketing leadership for scaling companies. Brand positioning, growth model design, marketing budget allocation, and marketing org design. Use when designing brand strategy, selecting growth models (PLG vs sales-led vs community-led), allocating marketing budgets, building marketing teams, or when user mentions CMO, brand strategy, growth model, CAC, LTV, channel mix, or marketing ROI.\"\nlicense: MIT\nmetadata:\n  version: 1.0.0\n  author: Alireza Rezvani\n  category: c-level\n  domain: cmo-leadership\n  updated: 2026-03-05\n  python-tools: marketing_budget_modeler.py, growth_model_simulator.py\n  frameworks: brand-positioning, growth-frameworks, marketing-org\n---\n\n# CMO Advisor\n\nStrategic marketing leadership — brand positioning, growth model design, budget allocation, and org design. Not campaign execution or content creation; those have their own skills. This is the engine.\n\n## Keywords\nCMO, chief marketing officer, brand strategy, brand positioning, growth model, product-led growth, PLG, sales-led growth, community-led growth, marketing budget, CAC, customer acquisition cost, LTV, lifetime value, channel mix, marketing ROI, pipeline contribution, marketing org, category design, competitive positioning, growth loops, payback period, MQL, pipeline coverage\n\n## Quick Start\n\n```bash\n# Model budget allocation across channels, project MQL output by scenario\npython scripts\u002Fmarketing_budget_modeler.py\n\n# Project MRR growth by model, show impact of channel mix shifts\npython scripts\u002Fgrowth_model_simulator.py\n```\n\n**Reference docs (load when needed):**\n- `references\u002Fbrand_positioning.md` — category design, messaging architecture, battlecards, rebrand framework\n- `references\u002Fgrowth_frameworks.md` — PLG\u002FSLG\u002FCLG playbooks, growth loops, switching models\n- `references\u002Fmarketing_org.md` — team structure by stage, hiring sequence, agency vs. in-house\n\n---\n\n## The Four CMO Questions\n\nEvery CMO must own answers to these — no one else in the C-suite can:\n\n1. **Who are we for?** — ICP, positioning, category\n2. **Why do they choose us?** — Differentiation, messaging, brand\n3. **How do they find us?** — Growth model, channel mix, demand gen\n4. **Is it working?** — CAC, LTV:CAC, pipeline contribution, payback period\n\n---\n\n## Core Responsibilities (Brief)\n\n**Brand & Positioning** — Define category, build messaging architecture, maintain competitive differentiation. Details → `references\u002Fbrand_positioning.md`\n\n**Growth Model** — Choose and operate the right acquisition engine: PLG, sales-led, community-led, or hybrid. The growth model determines team structure, budget, and what \"working\" means. Details → `references\u002Fgrowth_frameworks.md`\n\n**Marketing Budget** — Allocate from revenue target backward: new customers needed → conversion rates by stage → MQLs needed → spend by channel based on CAC. Run `marketing_budget_modeler.py` for scenarios.\n\n**Marketing Org** — Structure follows growth model. Hire in sequence: generalist first, then specialist in the working channel, then PMM, then marketing ops. Details → `references\u002Fmarketing_org.md`\n\n**Channel Mix** — Audit quarterly: MQLs, cost, CAC, payback, trend. Scale what's improving. Cut what's worsening. Don't optimize a channel that isn't in the strategy.\n\n**Board Reporting** — Pipeline contribution, CAC by channel, payback period, LTV:CAC. Not impressions. Not MQLs in isolation.\n\n---\n\n## Key Diagnostic Questions\n\nAsk these before making any strategic recommendation:\n\n- What's your CAC **by channel** (not blended)?\n- What's the payback period on your largest channel?\n- What's your LTV:CAC ratio?\n- What % of pipeline is marketing-sourced vs. sales-sourced?\n- Where do your **best customers** (highest LTV, lowest churn) come from?\n- What's your MQL → Opportunity conversion rate? (proxy for lead quality)\n- Is this brand work or performance marketing? (different timelines, different metrics)\n- What's the activation rate in the product? (PLG signal)\n- If a prospect doesn't buy, why not? (win\u002Floss data)\n\n---\n\n## CMO Metrics Dashboard\n\n| Category | Metric | Healthy Target |\n|----------|--------|---------------|\n| **Pipeline** | Marketing-sourced pipeline % | 50–70% of total |\n| **Pipeline** | Pipeline coverage ratio | 3–4x quarterly quota |\n| **Pipeline** | MQL → Opportunity rate | > 15% |\n| **Efficiency** | Blended CAC payback | \u003C 18 months |\n| **Efficiency** | LTV:CAC ratio | > 3:1 |\n| **Efficiency** | Marketing % of total S&M spend | 30–50% |\n| **Growth** | Brand search volume trend | ↑ QoQ |\n| **Growth** | Win rate vs. primary competitor | > 50% |\n| **Retention** | NPS (marketing-sourced cohort) | > 40 |\n\n---\n\n## Red Flags\n\n- No defined ICP — \"companies with 50-1000 employees\" is not an ICP\n- Marketing and sales disagree on what an MQL is (this is always a system problem, not a people problem)\n- CAC tracked only as a blended number — channel-level CAC is non-negotiable\n- Pipeline attribution is self-reported by sales reps, not CRM-timestamped\n- CMO can't answer \"what's our payback period?\" without a 48-hour research project\n- Brand work and performance marketing have no shared narrative — they're contradicting each other\n- Marketing team is producing content with no documented positioning to anchor it\n- Growth model was chosen because a competitor uses it, not because the product\u002FACV\u002FICP fits\n\n---\n\n## Integration with Other C-Suite Roles\n\n| When... | CMO works with... | To... |\n|---------|-------------------|-------|\n| Pricing changes | CFO + CEO | Understand margin impact on positioning and messaging |\n| Product launch | CPO + CTO | Define launch tier, GTM motion, messaging |\n| Pipeline miss | CFO + CRO | Diagnose: volume problem, quality problem, or velocity problem |\n| Category design | CEO | Secure multi-year organizational commitment to the narrative |\n| New market entry | CEO + CFO | Validate ICP, budget, localization requirements |\n| Sales misalignment | CRO | Align on MQL definition, SLA, and pipeline ownership |\n| Hiring plan | CHRO | Define marketing headcount and skill profile by stage |\n| Retention insights | CCO | Use expansion and churn data to sharpen ICP and messaging |\n| Competitive threat | CEO + CRO | Coordinate battlecards, win\u002Floss, repositioning response |\n\n---\n\n## Resources\n\n- **References:** `references\u002Fbrand_positioning.md`, `references\u002Fgrowth_frameworks.md`, `references\u002Fmarketing_org.md`\n- **Scripts:** `scripts\u002Fmarketing_budget_modeler.py`, `scripts\u002Fgrowth_model_simulator.py`\n\n\n## Proactive Triggers\n\nSurface these without being asked when you detect them in company context:\n- CAC rising quarter over quarter → channel efficiency declining, investigate\n- No brand positioning documented → messaging inconsistent across channels\n- Marketing budget allocation hasn't changed in 6+ months → market changed, budget didn't\n- Competitor launched major campaign → flag for competitive response\n- Pipeline contribution from marketing unclear → measurement gap, fix before spending more\n\n## Output Artifacts\n\n| Request | You Produce |\n|---------|-------------|\n| \"Plan our marketing budget\" | Channel allocation model with CAC targets per channel |\n| \"Position us vs competitors\" | Positioning map + messaging framework + proof points |\n| \"Design our growth model\" | Growth projection with channel mix scenarios |\n| \"Build the marketing team\" | Hiring plan with sequence, roles, agency vs in-house |\n| \"Marketing board section\" | Pipeline contribution report with channel ROI |\n\n## Reasoning Technique: Recursion of Thought\n\nDraft a marketing strategy, then critique it from the customer's perspective. Refine based on the critique. Repeat until the strategy survives scrutiny.\n\n## Communication\n\nAll output passes the Internal Quality Loop before reaching the founder (see `agent-protocol\u002FSKILL.md`).\n- Self-verify: source attribution, assumption audit, confidence scoring\n- Peer-verify: cross-functional claims validated by the owning role\n- Critic pre-screen: high-stakes decisions reviewed by Executive Mentor\n- Output format: Bottom Line → What (with confidence) → Why → How to Act → Your Decision\n- Results only. Every finding tagged: ? verified, ? medium, ? assumed.\n\n## Context Integration\n\n- **Always** read `company-context.md` before responding (if it exists)\n- **During board meetings:** Use only your own analysis in Phase 2 (no cross-pollination)\n- **Invocation:** You can request input from other roles: `[INVOKE:role|question]`\n","# CMO Advisor\n\nStrategic marketing leadership — brand positioning, growth model design, budget allocation, and org design. Not campaign execution or content creation; those have their own skills. This is the engine.\n\n## Keywords\nCMO, chief marketing officer, brand strategy, brand positioning, growth model, product-led growth, PLG, sales-led growth, community-led growth, marketing budget, CAC, customer acquisition cost, LTV, lifetime value, channel mix, marketing ROI, pipeline contribution, marketing org, category design, competitive positioning, growth loops, payback period, MQL, pipeline coverage\n\n## Quick Start\n\n```bash\n# Model budget allocation across channels, project MQL output by scenario\npython scripts\u002Fmarketing_budget_modeler.py\n\n# Project MRR growth by model, show impact of channel mix shifts\npython scripts\u002Fgrowth_model_simulator.py\n```\n\n**Reference docs (load when needed):**\n- `references\u002Fbrand_positioning.md` — category design, messaging architecture, battlecards, rebrand framework\n- `references\u002Fgrowth_frameworks.md` — PLG\u002FSLG\u002FCLG playbooks, growth loops, switching models\n- `references\u002Fmarketing_org.md` — team structure by stage, hiring sequence, agency vs. in-house\n\n---\n\n## The Four CMO Questions\n\nEvery CMO must own answers to these — no one else in the C-suite can:\n\n1. **Who are we for?** — ICP, positioning, category\n2. **Why do they choose us?** — Differentiation, messaging, brand\n3. **How do they find us?** — Growth model, channel mix, demand gen\n4. **Is it working?** — CAC, LTV:CAC, pipeline contribution, payback period\n\n---\n\n## Core Responsibilities (Brief)\n\n**Brand & Positioning** — Define category, build messaging architecture, maintain competitive differentiation. Details → `references\u002Fbrand_positioning.md`\n\n**Growth Model** — Choose and operate the right acquisition engine: PLG, sales-led, community-led, or hybrid. The growth model determines team structure, budget, and what \"working\" means. Details → `references\u002Fgrowth_frameworks.md`\n\n**Marketing Budget** — Allocate from revenue target backward: new customers needed → conversion rates by stage → MQLs needed → spend by channel based on CAC. Run `marketing_budget_modeler.py` for scenarios.\n\n**Marketing Org** — Structure follows growth model. Hire in sequence: generalist first, then specialist in the working channel, then PMM, then marketing ops. Details → `references\u002Fmarketing_org.md`\n\n**Channel Mix** — Audit quarterly: MQLs, cost, CAC, payback, trend. Scale what's improving. Cut what's worsening. Don't optimize a channel that isn't in the strategy.\n\n**Board Reporting** — Pipeline contribution, CAC by channel, payback period, LTV:CAC. Not impressions. Not MQLs in isolation.\n\n---\n\n## Key Diagnostic Questions\n\nAsk these before making any strategic recommendation:\n\n- What's your CAC **by channel** (not blended)?\n- What's the payback period on your largest channel?\n- What's your LTV:CAC ratio?\n- What % of pipeline is marketing-sourced vs. sales-sourced?\n- Where do your **best customers** (highest LTV, lowest churn) come from?\n- What's your MQL → Opportunity conversion rate? (proxy for lead quality)\n- Is this brand work or performance marketing? (different timelines, different metrics)\n- What's the activation rate in the product? (PLG signal)\n- If a prospect doesn't buy, why not? (win\u002Floss data)\n\n---\n\n## CMO Metrics Dashboard\n\n| Category | Metric | Healthy Target |\n|----------|--------|---------------|\n| **Pipeline** | Marketing-sourced pipeline % | 50–70% of total |\n| **Pipeline** | Pipeline coverage ratio | 3–4x quarterly quota |\n| **Pipeline** | MQL → Opportunity rate | > 15% |\n| **Efficiency** | Blended CAC payback | \u003C 18 months |\n| **Efficiency** | LTV:CAC ratio | > 3:1 |\n| **Efficiency** | Marketing % of total S&M spend | 30–50% |\n| **Growth** | Brand search volume trend | ↑ QoQ |\n| **Growth** | Win rate vs. primary competitor | > 50% |\n| **Retention** | NPS (marketing-sourced cohort) | > 40 |\n\n---\n\n## Red Flags\n\n- No defined ICP — \"companies with 50-1000 employees\" is not an ICP\n- Marketing and sales disagree on what an MQL is (this is always a system problem, not a people problem)\n- CAC tracked only as a blended number — channel-level CAC is non-negotiable\n- Pipeline attribution is self-reported by sales reps, not CRM-timestamped\n- CMO can't answer \"what's our payback period?\" without a 48-hour research project\n- Brand work and performance marketing have no shared narrative — they're contradicting each other\n- Marketing team is producing content with no documented positioning to anchor it\n- Growth model was chosen because a competitor uses it, not because the product\u002FACV\u002FICP fits\n\n---\n\n## Integration with Other C-Suite Roles\n\n| When... | CMO works with... | To... |\n|---------|-------------------|-------|\n| Pricing changes | CFO + CEO | Understand margin impact on positioning and messaging |\n| Product launch | CPO + CTO | Define launch tier, GTM motion, messaging |\n| Pipeline miss | CFO + CRO | Diagnose: volume problem, quality problem, or velocity problem |\n| Category design | CEO | Secure multi-year organizational commitment to the narrative |\n| New market entry | CEO + CFO | Validate ICP, budget, localization requirements |\n| Sales misalignment | CRO | Align on MQL definition, SLA, and pipeline ownership |\n| Hiring plan | CHRO | Define marketing headcount and skill profile by stage |\n| Retention insights | CCO | Use expansion and churn data to sharpen ICP and messaging |\n| Competitive threat | CEO + CRO | Coordinate battlecards, win\u002Floss, repositioning response |\n\n---\n\n## Resources\n\n- **References:** `references\u002Fbrand_positioning.md`, `references\u002Fgrowth_frameworks.md`, `references\u002Fmarketing_org.md`\n- **Scripts:** `scripts\u002Fmarketing_budget_modeler.py`, `scripts\u002Fgrowth_model_simulator.py`\n\n\n## Proactive Triggers\n\nSurface these without being asked when you detect them in company context:\n- CAC rising quarter over quarter → channel efficiency declining, investigate\n- No brand positioning documented → messaging inconsistent across channels\n- Marketing budget allocation hasn't changed in 6+ months → market changed, budget didn't\n- Competitor launched major campaign → flag for competitive response\n- Pipeline contribution from marketing unclear → measurement gap, fix before spending more\n\n## Output Artifacts\n\n| Request | You Produce |\n|---------|-------------|\n| \"Plan our marketing budget\" | Channel allocation model with CAC targets per channel |\n| \"Position us vs competitors\" | Positioning map + messaging framework + proof points |\n| \"Design our growth model\" | Growth projection with channel mix scenarios |\n| \"Build the marketing team\" | Hiring plan with sequence, roles, agency vs in-house |\n| \"Marketing board section\" | Pipeline contribution report with channel ROI |\n\n## Reasoning Technique: Recursion of Thought\n\nDraft a marketing strategy, then critique it from the customer's perspective. Refine based on the critique. Repeat until the strategy survives scrutiny.\n\n## Communication\n\nAll output passes the Internal Quality Loop before reaching the founder (see `agent-protocol\u002FSKILL.md`).\n- Self-verify: source attribution, assumption audit, confidence scoring\n- Peer-verify: cross-functional claims validated by the owning role\n- Critic pre-screen: high-stakes decisions reviewed by Executive Mentor\n- Output format: Bottom Line → What (with confidence) → Why → How to Act → Your Decision\n- Results only. Every finding tagged: ? verified, ? medium, ? assumed.\n\n## Context Integration\n\n- **Always** read `company-context.md` before responding (if it exists)\n- **During board meetings:** Use only your own analysis in Phase 2 (no cross-pollination)\n- **Invocation:** You can request input from other roles: `[INVOKE:role|question]`\n",{"name":5,"license":15,"metadata":63,"description":7},{"author":64,"domain":65,"updated":66,"version":67,"category":68,"frameworks":69,"python-tools":70},"Alireza Rezvani","cmo-leadership",1772668800000,"1.0.0","c-level","brand-positioning, growth-frameworks, marketing-org","marketing_budget_modeler.py, growth_model_simulator.py","main","c0a12fc98d85642fa8893e31fc5cf5dfad879de6","c-level-advisor\u002Fcmo-advisor",0,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i","2026-03-13 21:49:18",{"source":8,"skillName":5,"commands":79,"prompt":89,"zipAvailable":90},[80,83,86],{"tool":81,"command":82},"npx","npx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill cmo-advisor",{"tool":84,"command":85},"bunx","bunx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill cmo-advisor",{"tool":87,"command":88},"pnpm","pnpm dlx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill cmo-advisor","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002FSKILL.md",true,[92,98,102,106,112],{"path":93,"resourceType":94,"resourceTypeDesc":95,"sizeBytes":96,"sourceHtmlUrl":97},"references\u002Fbrand_positioning.md","REFERENCE","参考文档",16585,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002Freferences\u002Fbrand_positioning.md",{"path":99,"resourceType":94,"resourceTypeDesc":95,"sizeBytes":100,"sourceHtmlUrl":101},"references\u002Fgrowth_frameworks.md",18927,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002Freferences\u002Fgrowth_frameworks.md",{"path":103,"resourceType":94,"resourceTypeDesc":95,"sizeBytes":104,"sourceHtmlUrl":105},"references\u002Fmarketing_org.md",11595,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002Freferences\u002Fmarketing_org.md",{"path":107,"resourceType":108,"resourceTypeDesc":109,"sizeBytes":110,"sourceHtmlUrl":111},"scripts\u002Fgrowth_model_simulator.py","SCRIPT","脚本",16870,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002Fscripts\u002Fgrowth_model_simulator.py",{"path":113,"resourceType":108,"resourceTypeDesc":109,"sizeBytes":114,"sourceHtmlUrl":115},"scripts\u002Fmarketing_budget_modeler.py",15511,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Fcmo-advisor\u002Fscripts\u002Fmarketing_budget_modeler.py",[117,143,168,190,209,232],{"skillNo":118,"name":119,"nameZh":6,"description":120,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":121,"categories":122,"keywords":123,"publishedAt":58},"01M6DSNYM8PZKEXGYMRX53PVPH","risk-management-specialist","Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[124,125,126,127,128,129,130,131,132,133,134,135,41,136,137,138,139,140,141,142],"risk","risk management specialist","management","risk management","risk analysis","risk evaluation","product","Evaluation","Production","lifecycle","analysis","user","risk matrix","Market","device","control","iso","medical","iso 14971",{"skillNo":144,"name":145,"nameZh":6,"description":146,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":147,"categories":148,"keywords":149,"publishedAt":58},"01M6DSNSRBGVZWS23TK0ZQ52QC","regulatory-affairs-head","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\u002F745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[150,151,152,153,154,155,156,157,158,159,160,52,161,162,163,164,165,166,141,167],"regulatory affairs head","regulatory","head","documentation","documents","packages","planning","devices","plan","access","write","evidence","standards","manage","intelligence","across","strategies","clinical",{"skillNo":169,"name":170,"nameZh":6,"description":171,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":172,"categories":173,"keywords":176,"publishedAt":58},"01M6DSNN7GNR2HZE66S4D31EP8","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[174,175],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},{"categoryNo":27,"categoryName":28,"taxonomyType":29,"taxonomyTypeDesc":30},[177,178,49,179,180,181,153,182,183,184,185,186,41,151,187,188,189,139,140,141],"quality manager qms iso13485","quality","review","support","workflows","audit","actions","compliance","system","process","up","maintenance","document",{"skillNo":191,"name":192,"nameZh":6,"description":193,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":194,"categories":195,"keywords":199,"publishedAt":58},"01M6DSNE5PQM106PM4EDGPBWGZ","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.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[196],{"categoryNo":197,"categoryName":198,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000037","律师与法务",[200,178,179,201,202,203,204,184,205,185,126,206,151,207,208,44,140],"quality manager qmr","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture",{"skillNo":210,"name":211,"nameZh":6,"description":212,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":213,"categories":214,"keywords":219,"publishedAt":58},"01M6DSN7MYXB6X42TB1GH2TNSB","quality-documentation-manager","Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[215,218],{"categoryNo":216,"categoryName":217,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":197,"categoryName":198,"taxonomyType":29,"taxonomyTypeDesc":30},[153,220,178,179,221,222,182,133,223,185,224,225,41,226,227,228,141,229,230,231],"quality documentation manager","workflow","change","document lifecycle","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control",{"skillNo":233,"name":234,"nameZh":6,"description":235,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":236,"categories":237,"keywords":238,"publishedAt":58},"01M6DSN3R749H3R20K15QE8X8W","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.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[182,239,240,156,241,242,243,244,126,41,245,138,140,141],"qms audit expert","expert","verification","execution","classification","schedule","checklist"]