Development

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.

When the user wants to write, rewrite, or improve marketing copy for any page — including homepage, landing pages, pricing pages, feature pages, about pages, or product pages. Also use when the user says "write copy for," "improve this copy," "rewrite this page," "marketing copy," "headline help," or "CTA copy." For email copy, see email-sequence. For popup copy, see popup-cro.

Constant-time testing detects timing side channels in cryptographic code. Use when auditing crypto implementations for timing vulnerabilities.

Executive leadership guidance for strategic decision-making, organizational development, and stakeholder management. Use when planning strategy, preparing board presentations, managing investors, developing organizational culture, making executive decisions, fundraising, or when user mentions CEO, strategic planning, board meetings, investor updates, organizational leadership, or executive strategy.

Feishu document read/write operations. Activate when user mentions Feishu docs, cloud docs, or docx links.

Transcribe audio via OpenAI Audio Transcriptions API (Whisper).

Agile product ownership for backlog management and sprint execution. Covers user story writing, acceptance criteria, sprint planning, and velocity tracking. Use for writing user stories, creating acceptance criteria, planning sprints, estimating story points, breaking down epics, or prioritizing backlog.

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

Write high-performing, persuasive, and authentic LinkedIn posts across any professional niche. Uses research-backed hooks, proven post structures, and LinkedIn-specific formatting to maximize reach, saves, comments, and profile actions. Use when creating LinkedIn posts, carousels-by-text, thought leadership, founder updates, case studies, hiring posts, launch posts, or converting X/Twitter ideas into LinkedIn content.

Use when about to claim work is complete, fixed, or passing, before committing or creating PRs - requires running verification commands and confirming output before making any success claims; evidence before assertions always

A comprehensive, language-agnostic debugging guide covering systematic methodologies, practical techniques, and common patterns with clear examples and structured approaches.

Gemini CLI for one-shot Q&A, summaries, and generation.