HIPAA Pre-Deployment Compliance Check
maziyarpanahi/openmed
Walks a data pipeline against the HIPAA Privacy and Security Rule checklist and produces a gap report before it processes patient data.
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies.
Install Regulatory Affairs Head
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install davila7/claude-code-templates regulatory-affairs-head --agent claude-codeProject scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .claude/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .claude/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.
Claude Code skills documentation · loads skills from .claude/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .claude/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.Claude Code copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$skill-installer install https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-headType this inside Codex. $skill-installer <name> installs a curated skill from openai/skills. The installer writes to $CODEX_HOME/skills (default ~/.codex/skills). Restart Codex if the skill does not show up.
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install davila7/claude-code-templates regulatory-affairs-head --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .agents/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .agents/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .agents/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.Codex copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install davila7/claude-code-templates regulatory-affairs-head --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .cursor/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.cursor/skills/ instead of .cursor/skills for a personal install.
Cursor skills documentation · loads skills from .cursor/skills/, .agents/skills/, .claude/skills/, .codex/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .cursor/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.Cursor copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gemini skills install https://github.com/davila7/claude-code-templates.git --path cli-tool/components/skills/enterprise-communication/regulatory-affairs-head--scope user (default) or --scope workspace; --path is the subfolder of the repo that holds the skill; --consent skips the security confirmation prompt.
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install davila7/claude-code-templates regulatory-affairs-head --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .gemini/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.gemini/skills/ instead of .gemini/skills for a personal install, then run /skills reload.
Gemini CLI skills documentation · loads skills from .gemini/skills/, .agents/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .gemini/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.Gemini CLI copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gh skill install davila7/claude-code-templates regulatory-affairs-headInstalls for Copilot at project scope by default; add --scope user for a personal install. Preview a skill first with gh skill preview. Needs GitHub CLI 2.90.0 or later (public preview).
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .github/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .github/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.copilot/skills/ instead of .github/skills for a personal install. Commit .github/skills so cloud agent and code review can use it.
GitHub Copilot skills documentation · loads skills from .github/skills/, .claude/skills/, .agents/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .github/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.GitHub Copilot copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install davila7/claude-code-templates regulatory-affairs-head --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head .opencode/skills/regulatory-affairs-head && rm -rf skills-srcUse ~/.config/opencode/skills/ instead of .opencode/skills for a personal install.
OpenCode skills documentation · loads skills from .opencode/skills/, .claude/skills/, .agents/skills/
Install the "regulatory-affairs-head" agent skill from https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head into .opencode/skills/regulatory-affairs-head/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "regulatory-affairs-head", then confirm the skill loads.OpenCode copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
Facts
- Skill name
regulatory-affairs-head- GitHub stars
- 33k
- Used in
- 1 other repo
- Token cost
- ~1.3k tokens
- SKILL.md length
- 437 words
- Files
- 5 (incl. scripts, references, assets)
- Skills in repo
- 479
- Repo updated
- First seen
- Licence
- MIT
At a glance
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies.
- Works in 4 steps: Strategic Regulatory Planning → Regulatory Submission Management → Cross-functional Team Leadership → …
- Regulatory strategy development
- SKILL.md covers Core Competencies, Regulatory Decision Framework, Key Performance Indicators… and Communication Protocols, plus 1 more section
- Runs Python scripts from its folder
What it does
Regulatory Affairs Head is an agent skill from davila7/claude-code-templates. Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
Its SKILL.md is about 1.3k tokens, which your agent loads only when the skill is triggered. The skill folder holds 7 other files, including scripts, reference files and assets (for example `references/eu-mdr-submission-guide.md`, `references/fda-submission-guide.md` and `scripts/regulatory_tracker.py`).
It sits in Legal & Compliance, covering Regulatory compliance. The repository describes itself as: CLI tool for configuring and monitoring Claude Code. The licence is MIT.
When your agent uses it
- Regulatory strategy development
- Submission planning
- Regulatory risk assessment
- Team coordination activities
Example prompts
- “/regulatory-affairs-head”
Requirements
- Python 3
Workflow steps
4 steps, taken from the step headings in SKILL.md.
What it can do on your machine
Read from SKILL.md and the folder at commit 79182c5. It shows what the files ask for, not the result of running them.
Tool permissions
Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.
From allowed-tools in the SKILL.md frontmatter.
Runs code
Ships 1 file in scripts/ (Python), which the agent can run.
From the folder's file list and the shell code blocks in SKILL.md.
Network
No URLs in SKILL.md.
From URLs in SKILL.md, links to its own repository left out.
Credentials
Names no API keys, tokens, secrets or passwords.
From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.
Context cost
Regulatory Affairs Head loads about 1.3k tokens when it runs, and up to ~3.1k if it reads all its reference files. Until then it costs about 98 tokens; SKILL.md has 437 words of instructions outside code blocks.
Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.
Safety
Auto-check passed
The automated check found no risky patterns in SKILL.md.
Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.
SKILL.md
The full file from davila7/claude-code-templates at commit 79182c5, republished under its MIT licence (© davila7). 437 words, ~1,315 tokens.
Download SKILL.mdSave it as
.claude/skills/regulatory-affairs-head/SKILL.md (or your agent's skills folder). This skill also uses 4 other files; get the full folder from GitHub.- name
- regulatory-affairs-head
- description
- Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
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.)
Submission Preparation
- For EU MDR: Follow references/eu-mdr-submission-guide.md
- For FDA: Follow references/fda-submission-guide.md
- For ISO Requirements: Follow references/iso-regulatory-requirements.md
- For Global Markets: Follow references/global-regulatory-pathways.md
Submission Review and Approval
- Manage regulatory authority communications
- Coordinate responses to regulatory questions
- Monitor approval timelines and dependencies
3. Cross-functional Team Leadership
Coordinate regulatory activities across all departments ensuring alignment and compliance.
Team Coordination Protocol:
- Weekly: Regulatory team meetings and cross-functional updates
- Monthly: Regulatory committee meetings for strategic planning
- Quarterly: Regulatory training and compliance assessments
- Handoff Requirements: Clear documentation for all team interactions
4. Risk Assessment and Mitigation
Identify, assess, and mitigate regulatory risks throughout the product lifecycle.
Risk Assessment Framework:
1. REGULATORY IMPACT ASSESSMENT
├── Market access implications
├── Timeline and resource impact
├── Competitive positioning effects
└── Post-market obligations
2. MITIGATION STRATEGY DEVELOPMENT
├── Preventive controls implementation
├── Contingency planning
├── Communication protocols
└── Monitoring and review processesRegulatory Decision Framework
Apply this framework for all strategic regulatory decisions:
Step 1: Regulatory Impact Assessment
- Evaluate market access implications
- Assess timeline and resource requirements
- Analyze risk-benefit profile
- Consider competitive landscape impact
Step 2: Stakeholder Alignment
- Secure internal team consensus
- Obtain senior management approval
- Validate with external regulatory consultants (if required)
Step 3: Implementation Planning
- Define clear milestones and deliverables
- Establish resource allocation and responsibility matrix
- Develop communication plan for all stakeholders
Step 4: Monitoring and Review
- Implement regular progress checkpoints
- Integrate regulatory authority feedback
- Maintain continuous improvement process
Show full SKILL.md (132 more words)Show less
Key Performance Indicators (KPIs)
Monitor these regulatory performance metrics:
- Submission approval rates and timelines
- Regulatory authority interaction efficiency
- Cross-functional project coordination effectiveness
- Regulatory risk mitigation success rate
- Global market access achievement
Communication Protocols
For Regulatory Updates: Use standardized templates in assets/communication-templates/ For Regulatory Submissions: Follow checklists in references/submission-checklists/ For Team Training: Utilize materials in assets/training-materials/ For Escalations: Follow protocols in references/escalation-procedures.md
Resources
scripts/
regulatory_tracker.py: Automated submission status monitoringcompliance_checker.py: Regulatory compliance verification toolsubmission_timeline.py: Project timeline management and reporting
references/
eu-mdr-submission-guide.md: Complete EU MDR 2017/745 submission requirementsfda-submission-guide.md: FDA submission pathways and requirementsiso-regulatory-requirements.md: ISO 13485 and related standardsglobal-regulatory-pathways.md: International regulatory requirementsescalation-procedures.md: Internal and external escalation protocols
assets/
communication-templates/: Standardized regulatory communication templatessubmission-checklists/: Comprehensive submission preparation checkliststraining-materials/: Regulatory training presentations and materialsregulatory-forms/: Standard regulatory forms and templates
© davila7, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
SKILL.md and 4 other files (scripts, references, assets) in cli-tool/components/skills/enterprise-communication/regulatory-affairs-head of davila7/claude-code-templates.
- SKILL.md
- assets/example_asset.txt
- references/eu-mdr-submission-guide.md
- references/fda-submission-guide.md
- scripts/regulatory_tracker.py
Open the folder on GitHubat commit 79182c5
Used in 1 other repository
We found 2 copies of this SKILL.md (exact, near-identical or edited) in other folders, from 1 other GitHub owner. This page covers the copy in davila7/claude-code-templates, which our catalogue first saw on October 7, 2026.
Compare with similar skills
Regulatory Affairs Head next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.
| Skill | Stars | Used in | Tokens | Auto-check | Licence | Repo updated |
|---|---|---|---|---|---|---|
| Regulatory Affairs Head this skilldavila7/claude-code-templates | 33k | 1 repos | ~1.3k | Automated safety check: Pass | MIT | |
| HIPAA Pre-Deployment Compliance Checkmaziyarpanahi/openmed | 5.5k | — | ~2k | Automated safety check: Pass | Apache-2.0 | |
| Hipaa ComplianceSushegaad/Claude-Skills-Governance-Risk-and-Compliance | 946 | 1 repos | ~2.3k | Automated safety check: Pass | MIT | |
| ISO Standards Readiness EvidenceK-Dense-AI/scientific-agent-skills | 48k | 1 repos | ~4.6k | Automated safety check: Notes | MIT | |
| Iso42001Sushegaad/Claude-Skills-Governance-Risk-and-Compliance | 946 | 1 repos | ~3.7k | Automated safety check: Pass | MIT | |
| Legal Compliance SearchSerein-81/financial_rag | 148 | — | ~1.6k | Automated safety check: Notes | None |
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Related
Categories
Questions about Regulatory Affairs Head
What does Regulatory Affairs Head do?
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Regulatory Affairs Head is an agent skill from davila7/claude-code-templates. Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies.
When should I use Regulatory Affairs Head?
Regulatory Affairs Head fits situations like: regulatory strategy development; submission planning; regulatory risk assessment; team coordination activities.
How do I install Regulatory Affairs Head in Claude Code?
Run `npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a claude-code`. Or copy the skill folder (cli-tool/components/skills/enterprise-communication/regulatory-affairs-head in davila7/claude-code-templates) into .claude/skills/regulatory-affairs-head in your project. Claude Code loads it when a task matches its description.
How do I install Regulatory Affairs Head in Codex?
Run `npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a codex`. Or copy the skill folder (cli-tool/components/skills/enterprise-communication/regulatory-affairs-head in davila7/claude-code-templates) into .agents/skills/regulatory-affairs-head in your project. Codex loads it when a task matches its description.
Can I use Regulatory Affairs Head in Cursor, Gemini CLI or GitHub Copilot?
Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add davila7/claude-code-templates --skill regulatory-affairs-head -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/regulatory-affairs-head, .gemini/skills/regulatory-affairs-head, .github/skills/regulatory-affairs-head and .opencode/skills/regulatory-affairs-head in your project.
What does Regulatory Affairs Head need to run?
Going by SKILL.md and its folder, Regulatory Affairs Head needs Python for the scripts in its folder. Our summary lists: Python 3.
Does Regulatory Affairs Head access the network?
SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.
Is Regulatory Affairs Head safe to install?
Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.
What licence does Regulatory Affairs Head use?
Regulatory Affairs Head is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Regulatory Affairs Head use?
About 1.3k tokens (SKILL.md is roughly 5.3k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 1.8k tokens, read only when the agent opens those files.
What are the alternatives to Regulatory Affairs Head?
Skills that share tags, products or a category with Regulatory Affairs Head: HIPAA Pre-Deployment Compliance Check (maziyarpanahi/openmed, 5.5k stars), Hipaa Compliance (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars), ISO Standards Readiness Evidence (K-Dense-AI/scientific-agent-skills, 48k stars) and Iso42001 (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Regulatory Affairs Head?
davila7 (a GitHub user) maintains it in davila7/claude-code-templates, which has 32,552 GitHub stars. The repository holds 479 skills in this directory. The repository was last updated on October 11, 2026.
Source: davila7/claude-code-templates on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.