Description: We are developing Amia, a regulatory automation SaaS platform that generates FDA and CE submission templates. We now want to extend it with LLM-powered automation that can populate and structure FDA submissions (e.g., IND Modules 2–3, 510(k), De Novo) into proper eCTD-ready format. We are looking for AI/LLM engineers (not consultants) to build software features that: • Take Amia’s auto-generated draft text as input. • Populate and organize into correct FDA submission modules/sections (IND, 510(k), De Novo). • Apply formatting rules: section naming, TOCs, bookmarks, hyperlinks, cross-references. • Run validation against FDA RTA/eCTD checklists to flag missing sections. • Generate structured outputs (Word, PDF, XML for eCTD). • Provide an interface/workflow for edits and versioning. Must-have skills: • Strong experience with LLM / NLP pipelines (OpenAI, Anthropic, HuggingFace, LangChain, etc.). • Backend / data engineering (document parsing, structuring, automated formatting). • Prior work with document automation (regulatory, legal, compliance, pharma, or similar). • Familiarity with FDA submission structure (IND/510(k)/De Novo, eCTD granularity). • Located in or overlapping with Pacific time zone (US, Canada, Latin America preferred). Nice-to-have: • Experience with RegTech, MedTech, or Pharma. • Familiarity with Lorenz DocuBridge / GlobalSubmit or other eCTD tools. • Knowledge of FDA, HIPAA, ISO 13485, or EU MDR standards. Engagement: • Start with a pilot module (IND Module 3 CMC) as proof-of-concept. • Expand to full multi-submission automation if successful. • Flexible budget depending on experience, ideally $40–$80/hr or fixed-price milestones. To Apply: • Share a short note on your AI/LLM projects with document automation. • Provide sample code snippets or project links (redacted if needed). • State your time zone and hours of overlap with PST. • Indicate your rate (hourly or per-milestone).