Document Control Specialist at Neuralink in Austin, TX

Summary: Neuralink is creating devices that enable a bi-directional interface with the brain. They are seeking a Document Control Specialist to support document control-related activities across various departments, ensuring compliance with regulatory standards and maintaining critical documentation. Responsibilities: - Sustain and improve document control systems across Neuralink in alignment with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and other GxP requirements - Organize GxP files (including study records, lab data, equipment logs, and audit documentation) into a traceable, trackable, and searchable system - Maintain archives for GxP studies and ensure proper retention, deprecation, and re-indexing as needed (including leading archive re-indexing projects to correct/improve indexing) - Assist in SOP development, revisions, periodic reviews, and maintenance of tables of contents - Assist with the maintenance of various study trackers, training assignments, master schedule(s), and the glossary - Facilitate the completion of deviations and investigations - Manage document lifecycles: versioning, deprecation of obsolete documents, and routing/approval workflows - Support the Regulatory department by organizing regulatory filings (e.g., new study submissions and supplements), managing uploads to the eTMF, and preparing routine submission documents (cover letters, annual reports) Required Qualifications: - Meticulous attention to detail and exceptional organizational skills - Excellent verbal and written communication skills - Strong multitasking abilities in a dynamic, fast-paced, and constantly changing environment - Proficiency with Google Suite (Docs, Sheets, etc.) and standard document management tools - Working knowledge of medical, scientific, and regulatory terminology Preferred Qualifications: - Bachelor's Degree in a relevant field, such as life sciences, engineering, technical writing/communications, regulatory affairs, or equivalent - Relevant experience working in highly regulated environments, such as the medical device or pharmaceutical industries Required Skills: Document control systems, FDA regulations 21 CFR Part 11, FDA regulations 21 CFR 58, FDA regulations 21 CFR 812, GxP requirements, Document management tools, Google Suite, Medical terminology, Scientific terminology, Regulatory terminology, Multitasking Benefits: An opportunity to change the world and work with some of the smartest and most talented experts from different fields, Growth potential; we rapidly advance team members who have an outsized impact, Excellent medical, dental, and vision insurance through a PPO plan, Paid holidays, Commuter benefits, Meals provided, Equity (RSUs) • Temporary Employees & Interns excluded•, 401(k) plan • Interns initially excluded until they work 1,000 hours•, Parental leave • Temporary Employees & Interns excluded•, Flexible time off • Temporary Employees & Interns excluded•