Regulatory Affairs & Quality Lead

Regulatory Affairs & Quality Lead

Location:

North Brunswick, New Jersey (on‑site) Company Overview

Sonder Research X is developing innovative cancer diagnostics by integrating pathology, advanced imaging, artificial intelligence, and complementary biological data. Our multidisciplinary team works across scientific, engineering, computational, and clinical disciplines to develop novel diagnostic technologies that improve cancer detection and patient care.

As Sonder advances toward clinical validation and commercialization, we are committed to building the regulatory and quality capabilities necessary to support sustainable growth while maintaining scientific excellence.

We are seeking a Regulatory Affairs & Quality Lead to establish and develop Sonder's Regulatory Affairs capability while strengthening the Quality systems needed to support the company's continued growth. This individual will own the development and execution of scalable regulatory strategies and roadmaps that support clinical validation, diagnostic development, regulatory readiness, and future commercialization, while also serving as the internal owner of Sonder's Quality Management System (QMS).

Working closely with Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership, this individual will translate evolving regulatory and quality requirements into practical strategies, processes, and organizational priorities. The role will provide regulatory leadership across multidisciplinary initiatives, ensure Quality systems remain effective and scalable, and engage specialized external expertise when appropriate.

This hands‑on leadership role is ideal for an experienced Regulatory Affairs professional who can assess what is required, establish practical regulatory and quality capabilities, personally drive implementation, and help Sonder successfully navigate its next stage of scientific, clinical, and commercial growth.

• Develop, own, and execute Sonder's regulatory strategy and roadmap supporting clinical validation, diagnostic development, regulatory readiness, and future commercialization.
• Assess applicable regulatory pathways and requirements for Sonder's evolving diagnostic technologies, including laboratory-developed tests (LDTs), in vitro diagnostics (IVDs), and companion diagnostic opportunities.
• Lead regulatory planning for submissions and agency interactions, coordinating internal activities and engaging specialized external regulatory expertise when appropriate.
• Monitor evolving FDA and other applicable regulatory requirements and translate regulatory developments into clear, actionable guidance for scientific, clinical, laboratory, product development, and leadership teams. Identify regulatory risks, requirements, and decision points early in development and recommend practical strategies to address them.

• Serve as the internal owner of Sonder's Quality Management System (QMS), ensuring the system effectively supports the company's scientific, clinical, regulatory, and operational needs. Implement, maintain, and continuously improve Quality processes, including SOP governance, document control, training, corrective and preventive actions (CAPA), change control, and quality documentation.
• Coordinate internal audits, support external inspections, and strengthen organizational readiness for increasing Quality and Regulatory requirements.
• Promote practical, sustainable Quality practices across the organization while ensuring systems remain appropriate for Sonder's stage of growth.

• Integrate Regulatory and Quality requirements into…