Agent Skills Directory

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.

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 2017/745; 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.

Cross-functional what-if modeling for cascading multi-variable scenarios. Unlike single-assumption stress testing, this models compound adversity across all business functions simultaneously. Use when facing complex risk scenarios, strategic decisions with major downside, or when the user asks 'what if X AND Y both happen?'

When the user wants to design, launch, or optimize a referral or affiliate program. Use when they mention 'referral program,' 'affiliate program,' 'word of mouth,' 'refer a friend,' 'incentive program,' 'customer referrals,' 'brand ambassador,' 'partner program,' 'referral link,' or 'growth through referrals.' Covers program mechanics, incentive design, and optimization — not just the idea of referrals but the actual system.

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.

International market expansion strategy. Market selection, entry modes, localization, regulatory compliance, and go-to-market by region. Use when expanding to new countries, evaluating international markets, planning localization, or building regional teams.

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.

Systematic competitor tracking that feeds CMO positioning, CRO battlecards, and CPO roadmap decisions. Use when analyzing competitors, building sales battlecards, tracking market moves, positioning against alternatives, or when user mentions competitive intelligence, competitive analysis, competitor research, battlecards, win/loss, or market positioning.

SaaS financial health advisor. Use when a user shares revenue or customer numbers, or mentions ARR, MRR, churn, LTV, CAC, NRR, or asks how their SaaS business is doing.

Contract & Proposal Writer

/em -stress-test — Business Assumption Stress Testing

Design, optimize, and communicate SaaS pricing — tier structure, value metrics, pricing pages, and price increase strategy. Use when building a pricing model from scratch, redesigning existing pricing, planning a price increase, or improving a pricing page. Trigger keywords: pricing tiers, pricing page, price increase, packaging, value metric, per seat pricing, usage-based pricing, freemium, good-better-best, pricing strategy, monetization, pricing page conversion, Van Westendorp. NOT for broader product strategy — use product-strategist for that. NOT for customer success or renewals — use customer-success-manager for expansion revenue.