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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, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.

日本語の概要は準備中です。原文の説明を表示しています。

Write internal company communications — 3P updates (Progress/Plans/Problems), company-wide newsletters, FAQ roundups, incident reports, leadership updates, status reports, project updates, and general internal comms. Use this skill any time the user asks to draft, edit, or format something meant for internal audiences. Trigger on keywords like "3P", "weekly update", "newsletter", "FAQ", "internal comms", "status report", "company update", "team update", "incident report", or any request to summarize work for leadership, teammates, or the broader company. Even casual requests like "write my update" or "summarize what my team did this week" should trigger this skill.

日本語の概要は準備中です。原文の説明を表示しています。

Strategic product leadership toolkit for Head of Product covering OKR cascade generation, quarterly planning, competitive landscape analysis, product vision documents, and team scaling proposals. Use when creating quarterly OKR documents, defining product goals or KPIs, building product roadmaps, running competitive analysis, drafting team structure or hiring plans, aligning product strategy across engineering and design, or generating cascaded goal hierarchies from company to team level.

日本語の概要は準備中です。原文の説明を表示しています。

When the user wants to write, improve, or build a sequence of B2B cold outreach emails to prospects who haven't asked to hear from them. Use when the user mentions 'cold email,' 'cold outreach,' 'prospecting emails,' 'SDR emails,' 'sales emails,' 'first touch email,' 'follow-up sequence,' or 'email prospecting.' Also use when they share an email draft that sounds too sales-y and needs to be humanized. Distinct from email-sequence (lifecycle/nurture to opted-in subscribers) — this is unsolicited outreach to new prospects. NOT for lifecycle emails, newsletters, or drip campaigns (use email-sequence).

日本語の概要は準備中です。原文の説明を表示しています。

Full content production pipeline — takes a topic from blank page to published-ready piece. Use when you need to execute content: write a blog post, article, or guide end-to-end. Triggers: 'write a post about', 'draft an article', 'create content for', 'help me write', 'I need a blog post'. NOT for content strategy or calendar planning (use content-strategy). NOT for repurposing existing content (use content-repurposing). NOT for social captions only.

日本語の概要は準備中です。原文の説明を表示しています。

/cs:office-hours <topic> — YC-style 6-question founder interrogation before any advice. Forces clarity on problem, customer, distribution, defensibility, capital, and founder fit. Use when a founder question is too vague to route — e.g. 'should we grow faster?' — or before drafting a strategy brief.

日本語の概要は準備中です。原文の説明を表示しています。

Use when a Head of People Ops, BizOps lead, or Internal Communications owner needs to draft and sequence an internal-only change-management communication — a re-org announcement, a tool rollout, a policy change, a leadership transition, a layoff, an acquisition close, or an internal product launch — and the audience is employees (not customers). Pairs Prosci ADKAR and Kotter's 8-step change model with deterministic stdlib-only Python tools to produce a sequenced touchpoint calendar, a Kotter-compliant primary announcement, an audience-segmented FAQ, and manager cascade talking points; industry-tuned via --profile {tech-startup, scaleup, enterprise, public-company, non-profit}. Triggers on "all-hands announcement", "change comms", "rollout comms", "re-org announcement", "manager talking points", "layoff comms".

日本語の概要は準備中です。原文の説明を表示しています。

Generate professional, jurisdiction-aware business documents: freelance contracts, project proposals, SOWs, NDAs, and MSAs. Structured Markdown output with docx conversion instructions. Covers US (Delaware), EU (GDPR), UK, and DACH (German law) jurisdictions. Not a substitute for legal counsel — use as strong starting points. Use when drafting a freelance contract, preparing a client proposal, writing an SOW for a new engagement, or producing an NDA before sharing sensitive material.

日本語の概要は準備中です。原文の説明を表示しています。

Use when a user asks to debug or fix failing GitHub PR checks that run in GitHub Actions; use `gh` to inspect checks and logs, summarize failure context, draft a fix plan, and implement only after explicit approval. Treat external providers (for example Buildkite) as out of scope and report only the details URL.

日本語の概要は準備中です。原文の説明を表示しています。

Prepare meeting materials with Notion context and Codex research; use when gathering context, drafting agendas/pre-reads, and tailoring materials to attendees.

日本語の概要は準備中です。原文の説明を表示しています。

Draft a detailed privacy policy covering data types, jurisdiction, GDPR and compliance considerations, and clauses needing legal review. Use when creating a privacy policy, updating data protection documentation, or preparing for compliance.

日本語の概要は準備中です。原文の説明を表示しています。

Identify grammar, logical, and flow errors in text and suggest targeted fixes without rewriting the entire text. Use when proofreading content, checking writing quality, or reviewing a draft.

日本語の概要は準備中です。原文の説明を表示しています。

Brainstorm team-level OKRs aligned with company objectives — qualitative objectives with measurable key results. Use when setting quarterly OKRs, aligning team goals with company strategy, drafting objectives, or learning how to write effective OKRs.

日本語の概要は準備中です。原文の説明を表示しています。

Publish, read, comment on, or edit markdown in Proof. Use for Proof links, sharing specs/plans/drafts, or publish handoffs from planning workflows; avoid proofread, math, evidence, or proof-of-concept meanings.

日本語の概要は準備中です。原文の説明を表示しています。

Draft launch or promotion copy for a shipped feature.

日本語の概要は準備中です。原文の説明を表示しています。

Maintain the slopus/happy open source project. Triage issues, draft closing comments, find duplicates, check if bugs are fixed on main, and engage with community contributors. NEVER posts comments or closes issues without showing exact text and getting approval first.

日本語の概要は準備中です。原文の説明を表示しています。

Find link prospects, discover contact paths, and draft outreach from SERPs and backlink signals.

日本語の概要は準備中です。原文の説明を表示しています。

Cut an OpenSEO release — bump the version, draft user-facing release notes from commits since the last tag, run a review + subagent-verification pass, and open a "release: vX.X.X" PR. Use when the user asks to prepare a release, bump the version, or write release notes.

日本語の概要は準備中です。原文の説明を表示しています。

Prepare and cut one signed NemoClaw semver release tag, then follow release workflows and draft the Announcement.

日本語の概要は準備中です。原文の説明を表示しています。

Draft a post-tag NemoClaw Announcement from the verified release range and shipped PRs. Use when summarizing a release.

日本語の概要は準備中です。原文の説明を表示しています。

Investigate and review evidence-backed workflows with Screenpipe tools and shared drafts.

日本語の概要は準備中です。原文の説明を表示しています。

Reconstruct a customer relationship from recorded interactions before answering or drafting a response.

日本語の概要は準備中です。原文の説明を表示しています。

Capture decisions and commitments after a meeting and draft a concise follow-up.

日本語の概要は準備中です。原文の説明を表示しています。

Queries and retrieves active security findings, external exposures, toxic combinations, vulnerabilities, threats, and sensitive data risks from Security Command Center on Google Cloud. Use when retrieving details for a security finding by its name, validating finding scope (e.g., verifying findingClass is TOXIC_COMBINATION, VULNERABILITY, EXTERNAL_EXPOSURE, or THREAT), or fetching finding details for triage. Don't use to draft remediations, apply patches, or execute configurations.

日本語の概要は準備中です。原文の説明を表示しています。