How does this skill help with the submission process?

It provides structured submission workflows, from pre-submission strategy and pathway selection to final review and response management, supported by specific checklists and documentation templates.

Can this skill be used to manage a regulatory team?

Yes, it includes leadership protocols, communication templates, and handoff requirements designed to coordinate activities across regulatory, engineering, and management teams.

What regulatory frameworks does this skill support?

The skill provides deep expertise in global standards including FDA (510k, PMA, De Novo), EU MDR 2017/745, ISO 13485, and international regulatory pathways for diverse global markets.

Is it suitable for SaMD (Software as a Medical Device) developers?

Absolutely. The skill is specifically tailored for HealthTech and MedTech, making it ideal for teams developing software-driven medical products that require rigorous regulatory oversight.

Regulatory Affairs Head

Name: Regulatory Affairs Head
Author: pur3v4d3r

bypur3v4d3r

•

Productivity & Workflow

Provides expert-level regulatory guidance and submission management for HealthTech and MedTech companies navigating global compliance frameworks.

About

The Regulatory Affairs Head skill equips Claude with the specialized knowledge of a Senior Regulatory Manager to navigate the complex landscape of HealthTech and MedTech compliance. It offers strategic guidance for global market access, including detailed submission frameworks for the FDA and EU MDR, ISO 13485 requirements, and cross-functional leadership protocols. This skill is essential for developing regulatory pathways, managing submission timelines, and ensuring rigorous risk assessment throughout the product lifecycle to accelerate market entry while maintaining high compliance standards.

Key Features

Strategic regulatory pathway analysis for FDA, EU MDR, and global markets
End-to-end submission management with structured checklists and templates
Risk assessment frameworks for market access and post-market surveillance
Cross-functional leadership protocols for aligning engineering and regulatory teams
Automated compliance tracking and submission timeline monitoring scripts
1 GitHub stars

Use Cases

Developing a comprehensive regulatory strategy for new Class II/III medical devices
Managing complex EU MDR 2017/745 transitions and technical file preparation
Coordinating cross-functional responses to regulatory authority inquiries

About

Key Features

Strategic regulatory pathway analysis for FDA, EU MDR, and global markets
End-to-end submission management with structured checklists and templates
Risk assessment frameworks for market access and post-market surveillance
Cross-functional leadership protocols for aligning engineering and regulatory teams
Automated compliance tracking and submission timeline monitoring scripts
1 GitHub stars

Use Cases

Developing a comprehensive regulatory strategy for new Class II/III medical devices
Managing complex EU MDR 2017/745 transitions and technical file preparation
Coordinating cross-functional responses to regulatory authority inquiries