Regulatory Specialist

Team Description:

As a Regulatory Specialist at Neuralink, you will be part of the Quality Assurance (QA) Team. QA has a blend of specialists who are responsible for ensuring compliance by maintaing study protocols, study records, auditing, training compliance and meet applicable regulatory requirements (domestic and international).

Job Responsibilities and Description:

• Audit, monitor, and ensure compliance for Good Laboratory Practices (GLP) studies and clinical trials per Good Clinical Practice (GCP) requirements.
• Maintain a working knowledge of the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) requirements (21 CFR 11, 21 CFR 58, and 21 CFR 812) to establish real-time support for good practice (GxP) operations.
• Support and author regulatory submissions (FDA and international regulatory submissions).
• Support external notified body audits including from the FDA.
• Author and review standard operating procedures (SOPs) for compliance and regulatory requirements.
• Support labeling processes for packaging artwork, content review, and development. Manage a training program for the company.
  

Minimum requirements:

Master’s degree or foreign equivalent in Biotechnology, Biochemistry, Molecular Biology, or a related field, plus two (2) years of experience as a Research Specialist, Quality Assurance Specialist, Regulatory Associate, or related occupation.

Must have experience with the following:

• Good Laboratory Practices (GLP) and Good Clinical Practice (GCP) processes;
• Food and Drug Administration (FDA) Code of Federal Regulations (CFR) requirements and regulatory pathways;
• Collaborating with and training personnel;
• Regulatory documentation and compliance with federal and local policies;
• Preparing and submitting protocols and supporting documents to regulatory bodies;
• Handling clinical trial documentation and clinical trial-related regulatory processes;
• Planning and coordinating strategies to improve existing standard operating procedures (SOPs) related to regulatory affairs;
• Iidentifying quality and performance improvement opportunities and collaborating with staff in the development of action plans to improve quality.

To apply, submit resume to: [email protected]