Clinical Quality Specialist

Team Description:

Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance.

Job Description and Responsibilities:

As a Clinical Quality Specialist, you will conduct audits and ensure that clinical personnel across Neuralink operate within U.S. FDA regulatory requirements, GCP standards, and Neuralink policies and procedures. You will have the opportunity to work independently, exercising considerable latitude in determining objectives and solutions to various compliance challenges. The ideal candidate will display regular ingenuity and creativity. This role requires the application of extensive technical expertise and comprehensive knowledge of related disciplines. Additionally, you will be expected to:

• Conduct ongoing compliance audits using standard evaluation tools for auditing/monitoring activities and ensuring adherence to regulatory requirements
• Identify and define audit scope and criteria, review and analyze evidence, document audit findings, and recommend improvements and corrective actions as needed
• Advise departments on compliance risks related to contract provisions and federal and state regulations
• Lead the front room for external clinical audits (e.g., FDA or other notified bodies)
• Perform root cause analyses when compliance, accreditation, or clinical gaps are identified, and report findings to leadership
• Support monitoring activities involving effective execution of corrective action requirements
• Lead clinical quality process improvement initiatives

Required Qualifications:

• Bachelor's degree in a relevant scientific or healthcare field
• 4+ years of experience in clinical quality assurance or related roles
• Proficiency in Good Clinical Practice (GCP) guidelines and regulatory requirements
• Strong quality assurance and analytical skills
• Excellent communication and collaboration abilities
• Experience with regulatory and technical writing
• Experience with international clinical trials (outside the USA)

Preferred Qualifications:

• Master’s in Regulatory Affairs or Clinical Affairs
• Experience with significant-risk medical device clinical trials
  

Additional Requirements and Competencies:

• Ability to travel to/from work in multiple states
• Willingness to work in environments where potential exposure to animal bodily fluids, including blood, may occur
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to perform core functions independently
• Strong attention to detail
• Adaptability to changing priorities and schedules
• Team-oriented and proactive mindset