{
  "id": "regulatory-affairs-head",
  "name": "regulatory-affairs-head",
  "description": "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.",
  "version": "1.0.0",
  "author": "alirezarezvani",
  "tags": [
    "quality",
    "regulatory strategy",
    "FDA submission",
    "EU MDR",
    "510(k)",
    "PMA approval",
    "CE marking",
    "regulatory pathway",
    "market access",
    "clinical evidence",
    "regulatory intelligence",
    "submission planning",
    "notified body"
  ],
  "entryPoint": "tool_chain",
  "category": "quality",
  "toolChain": [],
  "inputs": [],
  "outputs": [
    {
      "name": "result",
      "type": "string",
      "description": "Skill output"
    }
  ],
  "createdAt": "2026-04-27T00:40:32.546740Z",
  "updatedAt": "2026-04-27T00:40:32.546740Z"
}