Regulatory Affairs Head
v2.1.1Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathwa...
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byAlireza Rezvani@alirezarezvani
MIT-0
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LicenseMIT-0 · Free to use, modify, and redistribute. No attribution required.
Security Scan
OpenClaw
Benign
high confidencePurpose & Capability
Name and description (Regulatory Affairs for medical devices) match the included SKILL.md and reference guides. The single helper script implements a local regulatory submission tracker which is coherent with submission management and scheduling tasks.
Instruction Scope
SKILL.md focuses on regulatory strategy, submission workflows, and templates. It does not instruct the agent to read unrelated system files, environment variables, or contact unexpected external endpoints. No open-ended instructions requesting broad system context are present.
Install Mechanism
There is no install specification (instruction-only skill with supporting docs and one small script). Nothing is downloaded or written to system paths by an installer.
Credentials
The skill declares no required environment variables, secrets, or config paths. The included Python script uses only local file I/O (regulatory_submissions.json) and standard libraries — proportional to the stated purpose.
Persistence & Privilege
Skill does not set always:true and does not request persistent or elevated privileges. The script persists data to a local JSON file in the working directory (normal for a tracker).
Assessment
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.Like a lobster shell, security has layers — review code before you run it.
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License
MIT-0
Free to use, modify, and redistribute. No attribution required.