IVD Documentation Specialist for Regulatory Submissions

Tempus AI; Chicago (IL); On-site; USD 50,000 - 65,000; Full time

Benefits offered by this job

Medical benefits

Incentive compensation

RSUs

Job summary

Tempus AI in Chicago is seeking a documentation specialist to prepare, edit, and file quality system documents for regulatory submissions related to diagnostic assays. You will collaborate with technical, development, quality, and regulatory teams to ensure compliant, well-organized documentation.

The role emphasizes accuracy, cross-functional teamwork, and supporting audits, with a competitive salary and comprehensive benefits.

Qualifications

• Bachelor’s degree and 2+ years of documentation experience in the medical device industry.
• Organized, detail oriented, and able to work with cross-functional teams.
• Excellent written and verbal communication skills.

Responsibilities

• Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing.
• Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes.
• Track batch records and checklists produced during IVD clinical validations and ensure compliance.
• Maintain appropriate filing systems.
• Documentation review for consistency and compliance.
• Help oversee implementation of new documentation and version control.
• Serve as a point of contact for documentation retrieval.
• Aid in preparation for internal and external audits.
• Manage multiple sources of information for documentation purposes.
• Help to continuously improve IVD and LDT development documentation and processes.

Skills

Documentation

Detail oriented

Written communication

Verbal communication

Cross-functional teamwork

Education

Bachelor's degree

Job description

Tempus AI in Chicago is seeking a documentation specialist to prepare, edit, and file quality system documents for regulatory submissions related to diagnostic assays. You will collaborate with technical, development, quality, and regulatory teams to ensure compliant, well-organized documentation.

The role emphasizes accuracy, cross-functional teamwork, and supporting audits, with a competitive salary and comprehensive benefits.