About the job
About Neuralink:
At Neuralink, we are pioneering cutting-edge technology to forge a direct link between the brain and external devices. Our innovative devices aim to restore mobility to those with paralysis, vision to the visually impaired, and to transform human interaction with digital environments.
Team Description:
Become a vital member of Neuralink's Quality Team, a collective of skilled professionals dedicated to establishing and maintaining exceptional quality and compliance frameworks. Our focus is to surpass regulatory standards and industry best practices, facilitating the rapid and safe advancement of Neuralink's groundbreaking technologies.
Job Description and Responsibilities:
Neuralink is in search of a meticulous Document Control Specialist who will be instrumental in overseeing document control activities across the organization. This pivotal role will involve organizing and managing essential documentation across various departments including preclinical, manufacturing, engineering, quality, and regulatory. You will play a key role in enhancing processes, archiving, and compliance tracking to ensure traceability, version control, and audit readiness in a highly regulated environment. Your responsibilities will also include:
- Enhancing and maintaining document control systems in accordance with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and GxP requirements.
- Structuring GxP files (including study records, lab data, equipment logs, and audit documentation) into an accessible, traceable, and searchable system.
- Overseeing archives for GxP studies and ensuring proper retention, deprecation, and re-indexing as necessary.
- Assisting in the development, revision, and periodic review of Standard Operating Procedures (SOPs) and maintaining corresponding tables of contents.
- Supporting the upkeep of study trackers, training assignments, master schedules, and glossaries.
- Facilitating the management of deviations and investigations.
- Handling document lifecycles, including versioning, deprecation of outdated documents, and approval workflows.
- Assisting the Regulatory department by organizing regulatory filings, managing eTMF uploads, and preparing routine submission documents.

