Agent Skills Directory

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.

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.

Plan resource capacity — workload analysis and utilization forecasting. Use when heading into quarterly planning, the team feels overallocated and you need the numbers, deciding whether to hire or deprioritize, or stress-testing whether upcoming projects fit the people you have.

Create a change management request with impact analysis and rollback plan. Use when proposing a system or process change that needs approval, preparing a change record for CAB review, documenting risk and rollback steps before a deployment, or planning stakeholder communications for a rollout.

Identify, assess, and mitigate operational risks. Trigger with "what are the risks", "risk assessment", "risk register", "what could go wrong", or when the user is evaluating risks associated with a project, vendor, process, or decision.

Generate a status report with KPIs, risks, and action items. Use when writing a weekly or monthly update for leadership, summarizing project health with green/yellow/red status, surfacing risks and decisions that need stakeholder attention, or turning a pile of project tracker activity into a readable narrative.

Advanced Scrum Master skill for data-driven agile team analysis and coaching. Use when the user asks about sprint planning, velocity tracking, retrospectives, standup facilitation, backlog grooming, story points, burndown charts, blocker resolution, or agile team health. Runs Python scripts to analyse sprint JSON exports from Jira or similar tools: velocity_analyzer.py for Monte Carlo sprint forecasting, sprint_health_scorer.py for multi-dimension health scoring, and retrospective_analyzer.py for action-item and theme tracking. Produces confidence-interval forecasts, health grade reports, and improvement-velocity trends for high-performing Scrum teams.

Atlassian Jira expert for creating and managing projects, planning, product discovery, JQL queries, workflows, custom fields, automation, reporting, and all Jira features. Use for Jira project setup, configuration, advanced search, dashboard creation, workflow design, and technical Jira operations.

Cascades strategy from boardroom to individual contributor. Detects and fixes misalignment between company goals and team execution. Covers strategy articulation, cascade mapping, orphan goal detection, silo identification, communication gap analysis, and realignment protocols. Use when teams are pulling in different directions, OKRs don't connect, departments optimize locally at company expense, or when user mentions alignment, strategy cascade, silo, conflicting OKRs, or strategy communication.

Cross-functional organizational health check combining signals from all C-suite roles. Scores 8 dimensions on a traffic-light scale with drill-down recommendations. Use when assessing overall company health, preparing for board reviews, identifying at-risk functions, or when user mentions org health, health check, or health dashboard.

M&A strategy for acquiring companies or being acquired. Due diligence, valuation, integration, and deal structure. Use when evaluating acquisitions, preparing for acquisition, M&A due diligence, integration planning, or deal negotiation.

/em -postmortem — Honest Analysis of What Went Wrong