{
  "id": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
  "_kind": "LibraryAgent",
  "_file": "generated-library/agents.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "regulatory-submission-strategist",
    "description": "Agent specialized in regulatory pathway determination, submission strategy, and timeline planning",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/agents/regulatory-submission-strategist/AGENT.md",
    "specialization": "biomedical-engineering",
    "role": "Senior Regulatory Affairs Manager",
    "expertise": [
      "FDA regulatory pathways (510(k), De Novo, PMA)",
      "EU MDR compliance and CE marking",
      "International regulatory strategy",
      "Pre-submission meeting preparation",
      "Regulatory risk assessment",
      "Submission timeline development"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "skill-area:compliance-automation",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "role:compliance-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-agent:biomedical-engineering--regulatory-submission-strategist",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}