Regulatory Systems Validation Analyst

Caris MPI, Inc.; Phoenix (AZ); On-site; USD 60,000 - 90,000; Full time

Job summary

Caris Life Sciences seeks a qualified professional to ensure equipment compliance with regulatory requirements and GDP across asset lifecycles. Responsibilities include instrument requalification, report authoring, and audit support, with cross-functional collaboration across QA, IT, Lab, and Systems Engineering.

The role requires a degree in engineering or sciences, knowledge of CAP/CLIA/ISO 13485/21 CFR Part 820, and experience in a regulated lab environment; Lean Six Sigma is a plus.

Qualifications

• Knowledge of quality systems requirements per CAP/CLIA, ISO 13485 and 21 CFR Part 820.
• GDP data/document handling and record-keeping
• Experience in regulated laboratory environments (1–2 years preferred)
• MS Office Suite proficiency (Word, Excel, Outlook)

Responsibilities

• Ensure equipment verification records comply with regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR).
• Collaborate on requalification of instrumentation to maintain compliance and efficiency.
• Author/review cross-correlation reports for molecular, IHC and liquid profiling workflows.
• Support SOP creation, review, and implementation; manage company records per regulatory policies.
• Participate in internal/external audits and provide required documentation.

Skills

QMS knowledge

GDP adherence

Regulatory compliance

MS Office proficiency

Education

Bachelor's degree (engineering, biological science, computer science, or similar)

Master's degree (engineering, biological science, computer science, or similar)

Job description

Caris Life Sciences seeks a qualified professional to ensure equipment compliance with regulatory requirements and GDP across asset lifecycles. Responsibilities include instrument requalification, report authoring, and audit support, with cross-functional collaboration across QA, IT, Lab, and Systems Engineering.

The role requires a degree in engineering or sciences, knowledge of CAP/CLIA/ISO 13485/21 CFR Part 820, and experience in a regulated lab environment; Lean Six Sigma is a plus.