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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, PM

Decision-grade entity research skill — produces a hypothesis-tested dossier on a specific company, person, nonprofit, or government org, not a generic profile. Forcing intake makes the user state their hypothesis upfront (what they already believe and want to verify or disprove) so the dossier tests it rather than confirms it. Output is an editable Word document (.docx) with verdict on the hypothe

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.

Analyzes meeting transcripts and recordings to surface behavioral patterns, communication anti-patterns, and actionable coaching feedback. Use this skill whenever the user uploads or points to meeting transcripts (.txt, .md, .vtt, .srt, .docx), asks about their communication habits, wants feedback on how they run meetings, requests speaking ratio analysis, mentions filler words or conflict avoidan

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

When the user wants to create or optimize popups, modals, overlays, slide-ins, or banners for conversion purposes. Also use when the user mentions "exit intent," "popup conversions," "modal optimization," "lead capture popup," "email popup," "announcement banner," or "overlay." For forms outside of popups, see form-cro. For general page conversion optimization, see page-cro.

Use when the user asks to track technical changes, create change records, manage TC lifecycles, or hand off work between AI sessions. Covers init/create/update/status/resume/close/export workflows for structured code change documentation.

Compact the current conversation into a handoff document for another agent to pick up. References existing artifacts (PRDs, plans, ADRs, issues, commits, diffs) by path or URL instead of duplicating them. Use when user wants to hand off the conversation to a fresh agent or starts a new session that picks up prior work.

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, wri

Compacts the current conversation into a handoff document so a fresh agent can continue the work, referencing existing artifacts instead of duplicating them. Saves to the OS temp directory. Activates when the user writes "handoff", "hand off", "compact the conversation", "summarize for the next session", "prepare a handoff doc", "pass this to another agent".

Supabase anon (public) key — safe for client-side use, protected by RLS