Does this skill include automated compliance tools?

The skill includes specialized scripts for automated submission status monitoring, compliance verification, and project timeline management.

How does this skill assist with FDA submissions?

It provides specialized guides and checklists for various FDA pathways, including 510(k), De Novo, and PMA, ensuring technical requirements and documentation standards are met.

Is this suitable for early-stage HealthTech startups?

Absolutely. It provides a strategic framework for regulatory pathway analysis, helping startups plan their market access timelines and resource allocation from day one.

Can it help with EU MDR 2017/745 compliance?

Yes, the skill includes specific submission guides and reference materials designed to navigate the European Medical Device Regulation requirements and technical file preparation.

Regulatory Affairs Head

Name: Regulatory Affairs Head
Author: alirezarezvani

byalirezarezvani

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1,039

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Productivity & Workflow

Provides expert-level leadership and strategic guidance for HealthTech and MedTech regulatory submissions and global compliance management.

This skill transforms Claude into a Senior Regulatory Affairs Manager capable of navigating the complex global landscapes of FDA, EU MDR, and ISO certifications. It provides structured frameworks for regulatory pathway analysis, submission planning (De Novo, 510(k), PMA), and risk-benefit assessments, ensuring MedTech companies achieve market access efficiently while maintaining rigorous compliance standards. By integrating cross-functional leadership protocols and automated monitoring scripts, it helps teams coordinate complex submission workflows and mitigate regulatory risks throughout the product lifecycle.

Key Features

01Structured risk assessment and mitigation frameworks for medical devices

02Comprehensive submission management from pre-submission to post-market surveillance

031,039 GitHub stars

04Strategic regulatory pathway analysis for FDA, EU MDR, and global markets

05Automated compliance verification and submission tracking scripts

06Cross-functional team coordination protocols and communication templates

Use Cases

01Determining the optimal regulatory pathway (e.g., 510(k) vs. De Novo) for a new medical device

02Preparing structured documentation and checklists for EU MDR 2017/745 compliance

03Establishing a standardized regulatory decision-making framework for HealthTech startups

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add alirezarezvani/claude-skills regulatory-affairs-head

For use in Claude.ai and ChatGPT

Download Skill