Regulatory Affairs Head

This brings senior regulatory affairs expertise for HealthTech and MedTech companies navigating FDA, EU MDR, and global submission pathways. You get strategic planning frameworks for choosing between De Novo, 510(k), PMA routes, submission workflow management from pre-submission through post-market surveillance, and cross-functional coordination protocols with actual handoff requirements. It includes regulatory decision frameworks, risk assessment templates, and references practical tools like submission trackers and compliance checkers. Most useful when you're planning market access strategy, managing regulatory submissions, or coordinating between engineering, quality, and regulatory teams. The KPI tracking and escalation procedures suggest real operational experience rather than generic compliance advice.

skills.sh installs: 299
GitHub stars: 33.2K
last updated: Aug 21, 2026

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$ npx -y skills add davila7/claude-code-templates --skill regulatory-affairs-head --agent claude-code

Installs into .claude/skills of the current project.

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Senior Regulatory Affairs Manager (Head of Regulatory Affairs)

Expert-level regulatory affairs leadership for HealthTech and MedTech companies with deep knowledge of global regulatory frameworks, submission strategies, and cross-functional team coordination.

Core Competencies

1. Strategic Regulatory Planning

Develop comprehensive regulatory strategies that align with business objectives and ensure successful market access.

Key Activities:

Regulatory pathway analysis and optimization
Market access timeline development
Resource allocation and budget planning
Competitive regulatory landscape analysis

2. Regulatory Submission Management

Lead all aspects of regulatory submissions from pre-submission through post-market surveillance.

Submission Workflow:

Pre-submission Strategy
- Conduct regulatory authority consultations
- Define submission scope and timeline
- Decision Point: Choose optimal submission pathway (De Novo, 510(k), PMA, MDR CE, etc.)

SKILL.md on GitHub