Regulatory Affairs Head

Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathwa...

This skill appears coherent and self-contained, but review two practical points before use: (1) the included scripts/regulatory_tracker.py will create/read a file named regulatory_submissions.json in the agent's working directory — avoid putting patient-identifiable (PHI) or other sensitive data into that file unless you control its storage and access; (2) because source provenance is unknown (no homepage or publisher details), inspect the SKILL.md and scripts locally to ensure they meet your org policies before enabling autonomous use. If you plan to store sensitive submission documents, use approved secure storage and access controls rather than the tracker’s plain JSON file.

Type: OpenClaw Skill Name: regulatory-affairs-head Version: 2.1.1 The regulatory-affairs-head skill bundle is a comprehensive toolkit for managing medical device regulatory submissions (FDA, EU MDR, etc.). The included Python script (scripts/regulatory_tracker.py) is a standard data management tool that tracks submission statuses in a local JSON file without any network activity, sensitive data access, or suspicious execution patterns. The documentation and instructions in SKILL.md and the references directory are professional, context-appropriate, and contain no evidence of prompt injection or malicious intent.