Topic: role-based-agents
204 skills in this topic.
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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.
borghei/Claude-Skills 71
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quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Use when conducting management reviews, setting quality objectives, tracking quality KPIs, assessing quality culture, overseeing regulatory compliance across jurisdictions, or preparing for Notified Body and FDA inspections. Provides quality system governance and performance monitoring per ISO 13485 Clause 5.5.2.
borghei/Claude-Skills 71
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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.
borghei/Claude-Skills 71
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regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Use when developing regulatory strategy, preparing FDA 510(k)/PMA/De Novo submissions, planning EU MDR CE marking, coordinating global market access, or monitoring regulatory intelligence. Provides pathway analysis, submission management, timeline planning, and cross-functional regulatory leadership.
borghei/Claude-Skills 71
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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.
borghei/Claude-Skills 71
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soc2-compliance-expert
SOC 2 Type I and Type II compliance management. Use when conducting SOC 2 readiness assessments, performing gap analysis against Trust Services Criteria, collecting audit evidence, validating infrastructure security controls, preparing for CPA firm audits, managing the observation period, or building continuous compliance programs. Covers all TSC categories (CC1-CC9, A1, PI1, C1, P1) with infrastructure validation for cloud, DNS, TLS, endpoints, and CI/CD pipelines.
borghei/Claude-Skills 71
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account-executive
Expert sales execution covering pipeline management, discovery, demos, negotiation, and deal closing. Use when qualifying opportunities, running MEDDIC discovery, building account plans, handling objections, structuring proposals, or forecasting pipeline.
borghei/Claude-Skills 71
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customer-success-manager
Expert customer success covering onboarding, adoption, retention, expansion, health scoring, and customer advocacy. Use when designing onboarding playbooks, calculating health scores, building QBR decks, planning renewal strategies, or identifying expansion opportunities.
borghei/Claude-Skills 71
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sales-engineer
Expert sales engineering covering technical demos, solution design, RFP responses, POC management, and technical objection handling. Use when preparing product demos, responding to RFPs/RFIs, scoping proof-of-concept projects, building competitive battle cards, or handling technical objections during sales cycles.
borghei/Claude-Skills 71
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sales-operations
Expert sales operations covering CRM management, sales analytics, territory planning, compensation design, and process optimization. Use when building pipeline reports, designing territories, setting quotas, creating comp plans, or auditing CRM data quality.
borghei/Claude-Skills 71
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solutions-architect
Expert solutions architecture covering technical requirements, solution design, integration planning, and enterprise architecture alignment. Use when conducting technical discovery, designing integration architectures, running security assessments, scoping proof-of-concept engagements, or creating solution architecture documents.
borghei/Claude-Skills 71
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churn-prevention
SaaS churn reduction covering cancel flow design, dynamic save offers, exit survey architecture, dunning sequences, payment recovery, win-back campaigns, and churn impact modeling.
borghei/Claude-Skills 71