[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6DRTY43B0W8QESHVRCYVXVZ":3,"skill-same:01M6DRTY43B0W8QESHVRCYVXVZ":120},{"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":23,"publishedAt":44,"linkOnly":45,"markdownContent":46,"markdownBody":47,"frontMatter":48,"refName":49,"commitSha":50,"skillDirectory":51,"forksCount":52,"repositoryHtmlUrl":53,"repositoryHomepageUrl":6,"ownerHtmlUrl":54,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":55,"install":56,"resources":69},"01M6DRTY43B0W8QESHVRCYVXVZ","sales-engineer",null,"Analyzes RFP\u002FRFI responses for coverage gaps, builds competitive feature comparison matrices, and plans proof-of-concept (POC) engagements for pre-sales engineering. Use when responding to RFPs, bids, or proposal requests; comparing product features against competitors; planning or scoring a customer POC or sales demo; preparing a technical proposal; or performing win\u002Floss competitor analysis. Handles tasks described as 'RFP response', 'bid response', 'proposal response', 'competitor comparison', 'feature matrix', 'POC planning', 'sales demo prep', or 'pre-sales engineering'.","zhangzhang-111-i\u002Fclaude-skills111","zhangzhang-111-i","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F251344927?v=4","01M6DRBP4NCM1ZCHTT0FW0SQHD","lixiying","01M6DRBPAMFDJSGQ69XPK9KM9J",4,"MIT","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fbusiness-growth\u002Fsales-engineer\u002FSKILL.md",[18],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000023","Skill与智能体开发","SCENARIO","使用场景",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"engineer","sales","sales engineer","as","customer","plans","feature","scoring","competitor analysis","use","rfi","coverage","technical","analysis","demo","product","planning","tasks","coverage gaps","proposal response","2026-11-10 10:12:30",false,"---\nname: \"sales-engineer\"\ndescription: Analyzes RFP\u002FRFI responses for coverage gaps, builds competitive feature comparison matrices, and plans proof-of-concept (POC) engagements for pre-sales engineering. Use when responding to RFPs, bids, or proposal requests; comparing product features against competitors; planning or scoring a customer POC or sales demo; preparing a technical proposal; or performing win\u002Floss competitor analysis. Handles tasks described as 'RFP response', 'bid response', 'proposal response', 'competitor comparison', 'feature matrix', 'POC planning', 'sales demo prep', or 'pre-sales engineering'.\n---\n\n# Sales Engineer Skill\n\n## 5-Phase Workflow\n\n### Phase 1: Discovery & Research\n\n**Objective:** Understand customer requirements, technical environment, and business drivers.\n\n**Checklist:**\n- [ ] Conduct technical discovery calls with stakeholders\n- [ ] Map customer's current architecture and pain points\n- [ ] Identify integration requirements and constraints\n- [ ] Document security and compliance requirements\n- [ ] Assess competitive landscape for this opportunity\n\n**Tools:** Run `rfp_response_analyzer.py` to score initial requirement alignment.\n\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json > phase1_rfp_results.json\n```\n\n**Output:** Technical discovery document, requirement map, initial coverage assessment.\n\n**Validation checkpoint:** Coverage score must be >50% and must-have gaps ≤3 before proceeding to Phase 2. Check with:\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json | python -c \"import sys,json; r=json.load(sys.stdin); print('PROCEED' if r['coverage_score']>50 and r['must_have_gaps']\u003C=3 else 'REVIEW')\"\n```\n\n---\n\n### Phase 2: Solution Design\n\n**Objective:** Design a solution architecture that addresses customer requirements.\n\n**Checklist:**\n- [ ] Map product capabilities to customer requirements\n- [ ] Design integration architecture\n- [ ] Identify customization needs and development effort\n- [ ] Build competitive differentiation strategy\n- [ ] Create solution architecture diagrams\n\n**Tools:** Run `competitive_matrix_builder.py` using Phase 1 data to identify differentiators and vulnerabilities.\n\n```bash\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json --format json > phase2_competitive.json\n\npython -c \"import json; d=json.load(open('phase2_competitive.json')); print('Differentiators:', d['differentiators']); print('Vulnerabilities:', d['vulnerabilities'])\"\n```\n\n**Output:** Solution architecture, competitive positioning, technical differentiation strategy.\n\n**Validation checkpoint:** Confirm at least one strong differentiator exists per customer priority before proceeding to Phase 3. If no differentiators found, escalate to Product Team (see Integration Points).\n\n---\n\n### Phase 3: Demo Preparation & Delivery\n\n**Objective:** Deliver compelling technical demonstrations tailored to stakeholder priorities.\n\n**Checklist:**\n- [ ] Build demo environment matching customer's use case\n- [ ] Create demo script with talking points per stakeholder role\n- [ ] Prepare objection handling responses\n- [ ] Rehearse failure scenarios and recovery paths\n- [ ] Collect feedback and adjust approach\n\n**Templates:** Use `assets\u002Fdemo_script_template.md` for structured demo preparation.\n\n**Output:** Customized demo, stakeholder-specific talking points, feedback capture.\n\n**Validation checkpoint:** Demo script must cover every must-have requirement flagged in `phase1_rfp_results.json` before delivery. Cross-reference with:\n```bash\npython -c \"import json; rfp=json.load(open('phase1_rfp_results.json')); [print('UNCOVERED:', r) for r in rfp['must_have_requirements'] if r['coverage']=='Gap']\"\n```\n\n---\n\n### Phase 4: POC & Evaluation\n\n**Objective:** Execute a structured proof-of-concept that validates the solution.\n\n**Checklist:**\n- [ ] Define POC scope, success criteria, and timeline\n- [ ] Allocate resources and set up environment\n- [ ] Execute phased testing (core, advanced, edge cases)\n- [ ] Track progress against success criteria\n- [ ] Generate evaluation scorecard\n\n**Tools:** Run `poc_planner.py` to generate the complete POC plan.\n\n```bash\npython scripts\u002Fpoc_planner.py poc_data.json --format json > phase4_poc_plan.json\n\npython -c \"import json; p=json.load(open('phase4_poc_plan.json')); print('Go\u002FNo-Go:', p['recommendation'])\"\n```\n\n**Templates:** Use `assets\u002Fpoc_scorecard_template.md` for evaluation tracking.\n\n**Output:** POC plan, evaluation scorecard, go\u002Fno-go recommendation.\n\n**Validation checkpoint:** POC conversion requires scorecard score >60% across all evaluation dimensions (functionality, performance, integration, usability, support). If score \u003C60%, document gaps and loop back to Phase 2 for solution redesign.\n\n---\n\n### Phase 5: Proposal & Closing\n\n**Objective:** Deliver a technical proposal that supports the commercial close.\n\n**Checklist:**\n- [ ] Compile POC results and success metrics\n- [ ] Create technical proposal with implementation plan\n- [ ] Address outstanding objections with evidence\n- [ ] Support pricing and packaging discussions\n- [ ] Conduct win\u002Floss analysis post-decision\n\n**Templates:** Use `assets\u002Ftechnical_proposal_template.md` for the proposal document.\n\n**Output:** Technical proposal, implementation timeline, risk mitigation plan.\n\n---\n\n## Python Automation Tools\n\n### 1. RFP Response Analyzer\n\n**Script:** `scripts\u002Frfp_response_analyzer.py`\n\n**Purpose:** Parse RFP\u002FRFI requirements, score coverage, identify gaps, and generate bid\u002Fno-bid recommendations.\n\n**Coverage Categories:** Full (100%), Partial (50%), Planned (25%), Gap (0%).  \n**Priority Weighting:** Must-Have 3×, Should-Have 2×, Nice-to-Have 1×.\n\n**Bid\u002FNo-Bid Logic:**\n- **Bid:** Coverage >70% AND must-have gaps ≤3\n- **Conditional Bid:** Coverage 50–70% OR must-have gaps 2–3\n- **No-Bid:** Coverage \u003C50% OR must-have gaps >3\n\n**Usage:**\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json            # human-readable\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json  # JSON output\npython scripts\u002Frfp_response_analyzer.py --help\n```\n\n**Input Format:** See `assets\u002Fsample_rfp_data.json` for the complete schema.\n\n---\n\n### 2. Competitive Matrix Builder\n\n**Script:** `scripts\u002Fcompetitive_matrix_builder.py`\n\n**Purpose:** Generate feature comparison matrices, calculate competitive scores, identify differentiators and vulnerabilities.\n\n**Feature Scoring:** Full (3), Partial (2), Limited (1), None (0).\n\n**Usage:**\n```bash\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json              # human-readable\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json --format json  # JSON output\n```\n\n**Output Includes:** Feature comparison matrix, weighted competitive scores, differentiators, vulnerabilities, and win themes.\n\n---\n\n### 3. POC Planner\n\n**Script:** `scripts\u002Fpoc_planner.py`\n\n**Purpose:** Generate structured POC plans with timeline, resource allocation, success criteria, and evaluation scorecards.\n\n**Default Phase Breakdown:**\n- **Week 1:** Setup — environment provisioning, data migration, configuration\n- **Weeks 2–3:** Core Testing — primary use cases, integration testing\n- **Week 4:** Advanced Testing — edge cases, performance, security\n- **Week 5:** Evaluation — scorecard completion, stakeholder review, go\u002Fno-go\n\n**Usage:**\n```bash\npython scripts\u002Fpoc_planner.py poc_data.json              # human-readable\npython scripts\u002Fpoc_planner.py poc_data.json --format json  # JSON output\n```\n\n**Output Includes:** Phased POC plan, resource allocation, success criteria, evaluation scorecard, risk register, and go\u002Fno-go recommendation framework.\n\n---\n\n## Reference Knowledge Bases\n\n| Reference | Description |\n|-----------|-------------|\n| `references\u002Frfp-response-guide.md` | RFP\u002FRFI response best practices, compliance matrix, bid\u002Fno-bid framework |\n| `references\u002Fcompetitive-positioning-framework.md` | Competitive analysis methodology, battlecard creation, objection handling |\n| `references\u002Fpoc-best-practices.md` | POC planning methodology, success criteria, evaluation frameworks |\n\n## Asset Templates\n\n| Template | Purpose |\n|----------|---------|\n| `assets\u002Ftechnical_proposal_template.md` | Technical proposal with executive summary, solution architecture, implementation plan |\n| `assets\u002Fdemo_script_template.md` | Demo script with agenda, talking points, objection handling |\n| `assets\u002Fpoc_scorecard_template.md` | POC evaluation scorecard with weighted scoring |\n| `assets\u002Fsample_rfp_data.json` | Sample RFP data for testing the analyzer |\n| `assets\u002Fexpected_output.json` | Expected output from rfp_response_analyzer.py |\n\n## Integration Points\n\n- **Marketing Skills** - Leverage competitive intelligence and messaging frameworks from `..\u002F..\u002Fmarketing-skill\u002F`\n- **Product Team** - Coordinate on roadmap items flagged as \"Planned\" in RFP analysis from `..\u002F..\u002Fproduct-team\u002F`\n- **C-Level Advisory** - Escalate strategic deals requiring executive engagement from `..\u002F..\u002Fc-level-advisor\u002F`\n- **Customer Success** - Hand off POC results and success criteria to CSM from `..\u002Fcustomer-success-manager\u002F`\n\n---\n\n**Last Updated:** February 2026\n**Status:** Production-ready\n**Tools:** 3 Python automation scripts\n**References:** 3 knowledge base documents\n**Templates:** 5 asset files\n","# Sales Engineer Skill\n\n## 5-Phase Workflow\n\n### Phase 1: Discovery & Research\n\n**Objective:** Understand customer requirements, technical environment, and business drivers.\n\n**Checklist:**\n- [ ] Conduct technical discovery calls with stakeholders\n- [ ] Map customer's current architecture and pain points\n- [ ] Identify integration requirements and constraints\n- [ ] Document security and compliance requirements\n- [ ] Assess competitive landscape for this opportunity\n\n**Tools:** Run `rfp_response_analyzer.py` to score initial requirement alignment.\n\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json > phase1_rfp_results.json\n```\n\n**Output:** Technical discovery document, requirement map, initial coverage assessment.\n\n**Validation checkpoint:** Coverage score must be >50% and must-have gaps ≤3 before proceeding to Phase 2. Check with:\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json | python -c \"import sys,json; r=json.load(sys.stdin); print('PROCEED' if r['coverage_score']>50 and r['must_have_gaps']\u003C=3 else 'REVIEW')\"\n```\n\n---\n\n### Phase 2: Solution Design\n\n**Objective:** Design a solution architecture that addresses customer requirements.\n\n**Checklist:**\n- [ ] Map product capabilities to customer requirements\n- [ ] Design integration architecture\n- [ ] Identify customization needs and development effort\n- [ ] Build competitive differentiation strategy\n- [ ] Create solution architecture diagrams\n\n**Tools:** Run `competitive_matrix_builder.py` using Phase 1 data to identify differentiators and vulnerabilities.\n\n```bash\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json --format json > phase2_competitive.json\n\npython -c \"import json; d=json.load(open('phase2_competitive.json')); print('Differentiators:', d['differentiators']); print('Vulnerabilities:', d['vulnerabilities'])\"\n```\n\n**Output:** Solution architecture, competitive positioning, technical differentiation strategy.\n\n**Validation checkpoint:** Confirm at least one strong differentiator exists per customer priority before proceeding to Phase 3. If no differentiators found, escalate to Product Team (see Integration Points).\n\n---\n\n### Phase 3: Demo Preparation & Delivery\n\n**Objective:** Deliver compelling technical demonstrations tailored to stakeholder priorities.\n\n**Checklist:**\n- [ ] Build demo environment matching customer's use case\n- [ ] Create demo script with talking points per stakeholder role\n- [ ] Prepare objection handling responses\n- [ ] Rehearse failure scenarios and recovery paths\n- [ ] Collect feedback and adjust approach\n\n**Templates:** Use `assets\u002Fdemo_script_template.md` for structured demo preparation.\n\n**Output:** Customized demo, stakeholder-specific talking points, feedback capture.\n\n**Validation checkpoint:** Demo script must cover every must-have requirement flagged in `phase1_rfp_results.json` before delivery. Cross-reference with:\n```bash\npython -c \"import json; rfp=json.load(open('phase1_rfp_results.json')); [print('UNCOVERED:', r) for r in rfp['must_have_requirements'] if r['coverage']=='Gap']\"\n```\n\n---\n\n### Phase 4: POC & Evaluation\n\n**Objective:** Execute a structured proof-of-concept that validates the solution.\n\n**Checklist:**\n- [ ] Define POC scope, success criteria, and timeline\n- [ ] Allocate resources and set up environment\n- [ ] Execute phased testing (core, advanced, edge cases)\n- [ ] Track progress against success criteria\n- [ ] Generate evaluation scorecard\n\n**Tools:** Run `poc_planner.py` to generate the complete POC plan.\n\n```bash\npython scripts\u002Fpoc_planner.py poc_data.json --format json > phase4_poc_plan.json\n\npython -c \"import json; p=json.load(open('phase4_poc_plan.json')); print('Go\u002FNo-Go:', p['recommendation'])\"\n```\n\n**Templates:** Use `assets\u002Fpoc_scorecard_template.md` for evaluation tracking.\n\n**Output:** POC plan, evaluation scorecard, go\u002Fno-go recommendation.\n\n**Validation checkpoint:** POC conversion requires scorecard score >60% across all evaluation dimensions (functionality, performance, integration, usability, support). If score \u003C60%, document gaps and loop back to Phase 2 for solution redesign.\n\n---\n\n### Phase 5: Proposal & Closing\n\n**Objective:** Deliver a technical proposal that supports the commercial close.\n\n**Checklist:**\n- [ ] Compile POC results and success metrics\n- [ ] Create technical proposal with implementation plan\n- [ ] Address outstanding objections with evidence\n- [ ] Support pricing and packaging discussions\n- [ ] Conduct win\u002Floss analysis post-decision\n\n**Templates:** Use `assets\u002Ftechnical_proposal_template.md` for the proposal document.\n\n**Output:** Technical proposal, implementation timeline, risk mitigation plan.\n\n---\n\n## Python Automation Tools\n\n### 1. RFP Response Analyzer\n\n**Script:** `scripts\u002Frfp_response_analyzer.py`\n\n**Purpose:** Parse RFP\u002FRFI requirements, score coverage, identify gaps, and generate bid\u002Fno-bid recommendations.\n\n**Coverage Categories:** Full (100%), Partial (50%), Planned (25%), Gap (0%).  \n**Priority Weighting:** Must-Have 3×, Should-Have 2×, Nice-to-Have 1×.\n\n**Bid\u002FNo-Bid Logic:**\n- **Bid:** Coverage >70% AND must-have gaps ≤3\n- **Conditional Bid:** Coverage 50–70% OR must-have gaps 2–3\n- **No-Bid:** Coverage \u003C50% OR must-have gaps >3\n\n**Usage:**\n```bash\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json            # human-readable\npython scripts\u002Frfp_response_analyzer.py assets\u002Fsample_rfp_data.json --format json  # JSON output\npython scripts\u002Frfp_response_analyzer.py --help\n```\n\n**Input Format:** See `assets\u002Fsample_rfp_data.json` for the complete schema.\n\n---\n\n### 2. Competitive Matrix Builder\n\n**Script:** `scripts\u002Fcompetitive_matrix_builder.py`\n\n**Purpose:** Generate feature comparison matrices, calculate competitive scores, identify differentiators and vulnerabilities.\n\n**Feature Scoring:** Full (3), Partial (2), Limited (1), None (0).\n\n**Usage:**\n```bash\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json              # human-readable\npython scripts\u002Fcompetitive_matrix_builder.py competitive_data.json --format json  # JSON output\n```\n\n**Output Includes:** Feature comparison matrix, weighted competitive scores, differentiators, vulnerabilities, and win themes.\n\n---\n\n### 3. POC Planner\n\n**Script:** `scripts\u002Fpoc_planner.py`\n\n**Purpose:** Generate structured POC plans with timeline, resource allocation, success criteria, and evaluation scorecards.\n\n**Default Phase Breakdown:**\n- **Week 1:** Setup — environment provisioning, data migration, configuration\n- **Weeks 2–3:** Core Testing — primary use cases, integration testing\n- **Week 4:** Advanced Testing — edge cases, performance, security\n- **Week 5:** Evaluation — scorecard completion, stakeholder review, go\u002Fno-go\n\n**Usage:**\n```bash\npython scripts\u002Fpoc_planner.py poc_data.json              # human-readable\npython scripts\u002Fpoc_planner.py poc_data.json --format json  # JSON output\n```\n\n**Output Includes:** Phased POC plan, resource allocation, success criteria, evaluation scorecard, risk register, and go\u002Fno-go recommendation framework.\n\n---\n\n## Reference Knowledge Bases\n\n| Reference | Description |\n|-----------|-------------|\n| `references\u002Frfp-response-guide.md` | RFP\u002FRFI response best practices, compliance matrix, bid\u002Fno-bid framework |\n| `references\u002Fcompetitive-positioning-framework.md` | Competitive analysis methodology, battlecard creation, objection handling |\n| `references\u002Fpoc-best-practices.md` | POC planning methodology, success criteria, evaluation frameworks |\n\n## Asset Templates\n\n| Template | Purpose |\n|----------|---------|\n| `assets\u002Ftechnical_proposal_template.md` | Technical proposal with executive summary, solution architecture, implementation plan |\n| `assets\u002Fdemo_script_template.md` | Demo script with agenda, talking points, objection handling |\n| `assets\u002Fpoc_scorecard_template.md` | POC evaluation scorecard with weighted scoring |\n| `assets\u002Fsample_rfp_data.json` | Sample RFP data for testing the analyzer |\n| `assets\u002Fexpected_output.json` | Expected output from rfp_response_analyzer.py |\n\n## Integration Points\n\n- **Marketing Skills** - Leverage competitive intelligence and messaging frameworks from `..\u002F..\u002Fmarketing-skill\u002F`\n- **Product Team** - Coordinate on roadmap items flagged as \"Planned\" in RFP analysis from `..\u002F..\u002Fproduct-team\u002F`\n- **C-Level Advisory** - Escalate strategic deals requiring executive engagement from `..\u002F..\u002Fc-level-advisor\u002F`\n- **Customer Success** - Hand off POC results and success criteria to CSM from `..\u002Fcustomer-success-manager\u002F`\n\n---\n\n**Last Updated:** February 2026\n**Status:** Production-ready\n**Tools:** 3 Python automation scripts\n**References:** 3 knowledge base documents\n**Templates:** 5 asset files\n",{"name":5,"description":7},"main","c0a12fc98d85642fa8893e31fc5cf5dfad879de6","business-growth\u002Fsales-engineer",0,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i","2026-03-13 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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",[],[128,129,130,131,132,133,39,134,135,136,37,137,33,138,139,140,141,142,143,144],"risk","risk management specialist","management","risk management","risk analysis","risk evaluation","Evaluation","Production","lifecycle","user","risk matrix","Market","device","control","iso","medical","iso 14971",{"skillNo":146,"name":147,"nameZh":6,"description":148,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":149,"categories":150,"keywords":151,"publishedAt":44},"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",[],[152,153,154,155,156,157,40,158,159,160,161,162,163,164,165,166,167,168,143,169],"regulatory affairs head","regulatory","head","documentation","documents","packages","devices","plan","access","write","strategy","evidence","standards","manage","intelligence","across","strategies","clinical",{"skillNo":171,"name":172,"nameZh":6,"description":173,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":174,"categories":175,"keywords":184,"publishedAt":44},"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",[176,179],{"categoryNo":177,"categoryName":178,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000015","视觉设计",{"categoryNo":180,"categoryName":181,"taxonomyType":182,"taxonomyTypeDesc":183},"01JBSEEDCAT000000000000032","设计师","PROFESSION","适用职业",[185,186,187,188,189,190,155,191,192,193,194,195,33,153,196,197,198,141,142,143],"quality manager qms iso13485","quality","design","review","support","workflows","audit","actions","compliance","system","process","up","maintenance","document",{"skillNo":200,"name":201,"nameZh":6,"description":202,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":203,"categories":204,"keywords":208,"publishedAt":44},"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",[205],{"categoryNo":206,"categoryName":207,"taxonomyType":182,"taxonomyTypeDesc":183},"01JBSEEDCAT000000000000037","律师与法务",[209,186,188,210,211,212,213,193,214,194,130,215,153,216,217,218,142],"quality manager qmr","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership",{"skillNo":220,"name":221,"nameZh":6,"description":222,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":223,"categories":224,"keywords":229,"publishedAt":44},"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",[225,228],{"categoryNo":226,"categoryName":227,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":206,"categoryName":207,"taxonomyType":182,"taxonomyTypeDesc":183},[155,230,186,188,231,232,191,136,233,194,234,235,33,236,237,238,143,239,240,241],"quality documentation manager","workflow","change","document lifecycle","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control",{"skillNo":243,"name":244,"nameZh":6,"description":245,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":246,"categories":247,"keywords":248,"publishedAt":44},"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",[],[191,249,250,40,251,252,253,254,130,33,255,140,142,143],"qms audit expert","expert","verification","execution","classification","schedule","checklist"]