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.

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.

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.

This skill should be used when the user asks to "design interview processes", "create hiring pipelines", "calibrate interview loops", "generate interview questions", "design competency matrices", "analyze interviewer bias", "create scoring rubrics", "build question banks", or "optimize hiring systems". Use for designing role-specific interview loops, competency assessments, and hiring calibration systems.

Build, measure, and evolve company culture as operational behavior — not wall posters. Covers mission/vision/values workshops, values-to-behaviors translation, culture code creation, culture health assessment, and cultural rituals by stage. Use when building company values, assessing culture health, designing cultural rituals, creating culture codes, handling culture clashes, or when user mentions culture, values, culture debt, founder culture, or culture code.