Regulatory Affairs & Quality Leader for LDTs

Sonder Research X; North Brunswick Township (NJ); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401(k)

Professional development budget

Coursera subscription

Job summary

Sonder Research X, based in North Brunswick, NJ, seeks a Regulatory Affairs & Quality Lead to build and lead regulatory and quality capabilities. The role focuses on advancing diagnostic assays through analytical validation and LDT implementation in a CLIA/CAP laboratory.

You will own the QMS, ensure scalable processes, and guide cross-functional teams through regulatory and quality challenges as the company moves toward clinical validation and commercialization.

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or related field.
• 5-8+ years of progressive Regulatory Affairs and/or Quality experience in regulated diagnostics or clinical laboratories.
• Experience supporting LDT development, validation, and regulatory readiness.
• Hands-on with QMS: SOPs, document control, CAPA, change control, training.
• Knowledge of CLIA and CAP; ability to translate requirements into practical processes.
• Strong project management, communication, and cross-functional collaboration.

Responsibilities

• Develop and execute scalable regulatory strategies and roadmaps for LDTs and diagnostics.
• Own QMS; ensure SOP governance, document control, CAPA, training, and change control.

Job description

Sonder Research X, based in North Brunswick, NJ, seeks a Regulatory Affairs & Quality Lead to build and lead regulatory and quality capabilities. The role focuses on advancing diagnostic assays through analytical validation and LDT implementation in a CLIA/CAP laboratory.

You will own the QMS, ensure scalable processes, and guide cross-functional teams through regulatory and quality challenges as the company moves toward clinical validation and commercialization.