Senior Bioinformatics Product Manager: Regulated Diagnostics

Tempus AI, Inc.; Chicago (IL); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Benefits package

Job summary

Tempus AI, Inc. is seeking a Sr. Technical Product Manager for Bioinformatics Software to lead regulation-driven product strategy and lifecycle for diagnostic software in oncology and related arenas.

You will collaborate with quality/regulatory teams, manage incidents, and prioritize feature requests while interfacing with engineering and product managers to ensure compliant, high-impact software solutions.

Qualifications

• Bachelor's or Master’s in a scientific discipline required.
• Significant experience in medical device development and regulatory submission.
• 2-4 years in diagnostics product development.
• Familiarity with US FDA and EU IVDR regulatory frameworks.
• Experience with diagnostic products, software regulatory requirements, and algorithms development.
• Top candidates will have significant experience in regulated device development.

Responsibilities

• Managing software development lifecycle processes.
• Engaging with the quality and regulatory team and supporting quality processes.
• Incident management: triage, coordinate, and resolve issues.
• Stakeholder support: provide dedicated and responsive support to users of the bioinformatics software.
• Feature request intake and prioritization: collect, prioritize, and manage feature requests.
• Interfacing with Product Managers of downstream engineering teams during implementation.
• Data contract management with downstream engineering teams.
• Documentation: maintain comprehensive and up-to-date documentation for all bioinformatics software.

Skills

Regulatory knowledge

Diagnostics product development

Medical device development

FDA/EU IVDR familiarity

Education

Bachelor's or Master's in a scientific discipline

Job description

Tempus AI, Inc. is seeking a Sr. Technical Product Manager for Bioinformatics Software to lead regulation-driven product strategy and lifecycle for diagnostic software in oncology and related arenas.

You will collaborate with quality/regulatory teams, manage incidents, and prioritize feature requests while interfacing with engineering and product managers to ensure compliant, high-impact software solutions.