Agent Skills Directory

Operations leadership for scaling companies. Process design, OKR execution, operational cadence, and scaling playbooks. Use when designing operations, setting up OKRs, building processes, scaling teams, analyzing bottlenecks, planning operational cadence, or when user mentions COO, operations, process improvement, OKRs, scaling, operational efficiency, or execution.

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

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.

Atlassian Confluence expert for creating and managing spaces, knowledge bases, and documentation. Configures space permissions and hierarchies, creates page templates with macros, sets up documentation taxonomies, designs page layouts, and manages content governance. Use when users need to build or restructure a Confluence space, design page hierarchies with permission structures, author or standardise documentation templates, embed Jira reports in pages, run knowledge base audits, or establish documentation standards and collaborative workflows.

Document a business process — flowcharts, RACI, and SOPs. Use when formalizing a process that lives in someone's head, building a RACI to clarify who owns what, writing an SOP for a handoff or audit, or capturing the exceptions and edge cases of how work actually gets done.

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.

Atlassian Template and Files Creator/Modifier expert for creating, modifying, and managing Jira and Confluence templates, blueprints, custom layouts, reusable components, and standardized content structures. Use when building org-wide templates, custom blueprints, page layouts, and automated content generation.

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.

Analyze and improve business processes. Trigger with "this process is slow", "how can we improve", "streamline this workflow", "too many steps", "bottleneck", or when the user describes an inefficient process they want to fix.

The meta-framework for how a company runs — the connective tissue between all C-suite roles. Covers operating system selection (EOS, Scaling Up, OKR-native, hybrid), accountability charts, scorecards, meeting pulse, issue resolution, and 90-day rocks. Use when setting up company operations, selecting a management framework, designing meeting rhythms, building accountability systems, implementing OKRs, or when user mentions EOS, Scaling Up, operating system, L10 meetings, rocks, scorecard, accountability chart, or quarterly planning.

Atlassian Administrator for managing and organizing Atlassian products (Jira, Confluence, Bitbucket, Trello), users, permissions, security, integrations, system configuration, and org-wide governance. Use when asked to add users to Jira, change Confluence permissions, configure access control, update admin settings, manage Atlassian groups, set up SSO, install marketplace apps, review security policies, or handle any org-wide Atlassian administration task.

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.