IVD R&D Documentation Specialist

Ambry Genetics Corporation; Chicago, Northern (IL, KY); Hybrid; USD 50,000 - 55,000; Full time

Job summary

Tempus is seeking a documentation-focused professional to support the IVD development team in creating and maintaining regulatory and quality documents for diagnostic assay submissions. The role emphasizes accuracy, organization, and cross-functional collaboration in a fast-paced environment.

The position requires a bachelor’s degree with 2+ years of documentation experience in the medical device industry, plus familiarity with ISO 13485 and FDA QMS submissions.

Qualifications

• Bachelor’s degree plus 2+ years of documentation experience in medical devices.
• Experience drafting regulatory and quality documentation for submissions.
• Ability to work with cross-functional teams and maintain accuracy.

Responsibilities

• Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing.
• Draft and edit SOPs, batch records, and work instructions for lab processes.
• Track batch records and checklists produced during IVD validations for compliance.
• Maintain filing systems and assist audits with documentation retrieval.
• Help implement new documentation and version control across projects.

Skills

Documentation experience

Organized and detail oriented

Excellent written and verbal skills

Team oriented

Education

Bachelor’s degree

Tools

QMS systems

Job description

Tempus is seeking a documentation-focused professional to support the IVD development team in creating and maintaining regulatory and quality documents for diagnostic assay submissions. The role emphasizes accuracy, organization, and cross-functional collaboration in a fast-paced environment.

The position requires a bachelor’s degree with 2+ years of documentation experience in the medical device industry, plus familiarity with ISO 13485 and FDA QMS submissions.