regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepar
Profile →npx skills add alirezarezvani/claude-skills --skill regulatory-affairs-head --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Head of Regulatory Affairs Regulatory strategy development, submission management, and global market access for medical device organizations. --- ## Table of Contents - [Regulatory Strategy Workflow](#regulatory-strategy-workflow) - [FDA Submission Workflow](#fda-submission-workflow) - [EU MDR Submission Workflow](#eu-mdr-submission-workflow) - [Global Market Access Workflow](#global-market-access-workflow) - [Regulatory Intelligence Workflow](#regulatory-intelligence-workflow) - [Decision Frameworks](#decision-frameworks) - [Tools and References](#tools-and-references) --- ## Regulatory Strategy Workflow Develop regulatory strategy aligned with business objectives and product characteristics. ### Workflow: New Product Regulatory Strategy 1. Gather product information: - Intended use and indications - Device classification (risk level) - Technology platform - Target markets and timeline 2. Identify applicable regulations per target market: - FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo - EU: MDR 2017/745, Notified Body requirements - Other markets: Health Canada, PMDA, NMPA, TGA 3. Determine optimal regulatory pathway: - Compare submission types (510(k) vs De Novo vs PMA) - Asse
- Table of Contents
- Regulatory Strategy Workflow
- Workflow: New Product Regulatory Strategy
- Regulatory Pathway Selection Matrix
- Regulatory Strategy Document Template
- FDA Submission Workflow
- Workflow: 510(k) Submission
- Workflow: PMA Submission
- FDA Submission Timeline
- Common FDA Deficiencies and Prevention
- EU MDR Submission Workflow
- Workflow: MDR Technical Documentation
- Clinical Evidence Requirements by Class
- Notified Body Selection Criteria
python regulatory_tracker.py --report status Submission Status Report — 2024-11-01
What does the regulatory-affairs-head skill do?
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepar
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill regulatory-affairs-head --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.