Document Control Specialist

Team Description:

Join the Quality Team at Neuralink, a group of dedicated professionals building and sustaining world-class quality and compliance frameworks from the group up. The Quality team focuses on exceeding regulatory requirements and industry best practices to enable safe and fast development of Neuralink’s innovative technologies.

Job Description and Responsibilities:

Neuralink is seeking a Document Control Specialist with strong organization skills to support document control-related activities company-wide. This role will serve as a foundational resource for organizing and managing critical documentation across the preclinical, manufacturing, engineering, quality, and regulatory departments. This position will support the maintenance, development, and scaling of processes, archiving, and compliance tracking—ensuring traceability, version control, and readiness for audits and submissions in a highly regulated environment.  Additionally, you will be expected to:

• 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

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

Texas Hourly Range:

$21 – $35/Hr USD