IVD Documentation & Regulatory Specialist

Tempus AI, Inc.; Chicago (IL); Hybrid; USD 50,000 - 55,000; Full time

Benefits offered by this job

Benefits package

Stock options

Medical benefits

Job summary

Tempus AI, Inc. is seeking a qualified documentation specialist to support the development and regulatory submission of diagnostic assays. Join a fast-paced molecular R&D environment and contribute to SOPs, batch records, and validation documentation.

The role emphasizes cross-functional collaboration with scientists and QA/regulatory professionals, with on-site work three days per week at our Chicago office. A bachelor’s degree plus 2+ years’ related experience is expected.

Qualifications

• Bachelor’s degree plus 2+ years of documentation experience in the medical device industry
• Organized and detail oriented
• Excellent written and verbal skills
• Ability to work well with cross functional teams
• Team driven
• Experience in a lab setting in life sciences and understanding of molecular biology is highly desirable
• Familiarity with a range of QMS systems and regulatory submissions
• Familiarity with ISO 13485 and FDA QSMR

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

Quality systems

Regulatory submissions

Cross-functional teamwork

Lab/biotech experience

Education

Bachelor’s degree

Tools

QMS familiarity

ISO 13485

FDA QSMR

Job description

Tempus AI, Inc. is seeking a qualified documentation specialist to support the development and regulatory submission of diagnostic assays. Join a fast-paced molecular R&D environment and contribute to SOPs, batch records, and validation documentation.

The role emphasizes cross-functional collaboration with scientists and QA/regulatory professionals, with on-site work three days per week at our Chicago office. A bachelor’s degree plus 2+ years’ related experience is expected.