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.

Run nf-core bioinformatics pipelines (rnaseq, sarek, atacseq) on sequencing data. Use when analyzing RNA-seq, WGS/WES, or ATAC-seq data—either local FASTQs or public datasets from GEO/SRA. Triggers on nf-core, Nextflow, FASTQ analysis, variant calling, gene expression, differential expression, GEO reanalysis, GSE/GSM/SRR accessions, or samplesheet creation.

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.

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.

This skill should be used when scientists need help with research problem selection, project ideation, troubleshooting stuck projects, or strategic scientific decisions. Use this skill when users ask to pitch a new research idea, work through a project problem, evaluate project risks, plan research strategy, navigate decision trees, or get help choosing what scientific problem to work on. Typical requests include "I have an idea for a project", "I'm stuck on my research", "help me evaluate this project", "what should I work on", or "I need strategic advice about my research".

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.

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.

/em -challenge — Pre-Mortem Plan Analysis

Senior Project Manager for enterprise software, SaaS, and digital transformation projects. Specializes in portfolio management, quantitative risk analysis, resource optimization, stakeholder alignment, and executive reporting. Uses advanced methodologies including EMV analysis, Monte Carlo simulation, WSJF prioritization, and multi-dimensional health scoring. Use when a user needs help with project plans, project status reports, risk assessments, resource allocation, project roadmaps, milestone tracking, team capacity planning, portfolio health reviews, program management, or executive-level project reporting — especially for enterprise-scale initiatives with multiple workstreams, complex dependencies, or multi-million dollar budgets.

Two-layer memory architecture for board meeting decisions. Manages raw transcripts (Layer 1) and approved decisions (Layer 2). Use when logging decisions after a board meeting, reviewing past decisions with /cs:decisions, or checking overdue action items with /cs:review. Invoked automatically by the board-meeting skill after Phase 5 founder approval.

/em -postmortem — Honest Analysis of What Went Wrong

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.