Quality & Regulatory Affairs Lead

Sonder Research X•North Brunswick, NJ

7h•Onsite

About The Position

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 Quality & Regulatory Affairs Lead to establish and strengthen the quality and regulatory capabilities needed to support Sonder's continued growth. This individual will lead the development and implementation of scalable quality systems, strengthen our Quality Management System (QMS), and help establish the regulatory strategies necessary to support clinical validation, regulatory readiness, and future commercialization. Working closely with Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership, this individual will integrate quality and regulatory requirements into product development and operational decision-making, provide practical guidance across multidisciplinary teams, and help ensure Sonder is prepared for increasing regulatory and quality requirements as our clinical and commercial activities advance. This hands-on leadership role is ideal for an experienced quality and regulatory professional who can translate applicable requirements into practical systems and processes, personally drive implementation, and establish evidence that those processes are effective and sustainable.

Requirements

Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or a related scientific discipline.
5–8+ years of progressive experience in Regulatory Affairs, Quality Systems, or a combination of both, in biotechnology, diagnostics, medical devices, or other regulated life sciences.
Working knowledge of FDA regulations and quality system requirements.
Experience supporting or developing Quality Management Systems, including SOP governance, document control, and audit readiness.
Strong project management, communication, and cross-functional collaboration skills.
Ability to thrive in a fast-paced, growth-stage biotechnology environment.

Nice To Haves

Experience supporting molecular diagnostics, pathology, digital pathology, AI-enabled healthcare technologies, or in vitro diagnostics.
Familiarity with CLIA, CAP, ISO 13485, and laboratory quality systems.
Experience supporting FDA submissions or regulatory agency interactions.
Experience building regulatory or quality capabilities within a startup or growth-stage organization.

Responsibilities

Develop, implement, and continuously improve Sonder's Quality Management System, including SOP governance, document control, training, corrective and preventive actions (CAPA), change control, and quality documentation.
Coordinate internal audits, support external inspections, and establish scalable quality processes appropriate for the company's stage of growth.
Foster a culture of quality by integrating practical, sustainable quality systems across the organization.
Partner with scientific, laboratory, and operational teams to integrate regulatory and quality requirements into research, laboratory operations, clinical development, and future commercialization activities.
Support laboratory quality initiatives and future CLIA readiness while ensuring regulatory and quality considerations are incorporated early into new scientific and operational initiatives.
Develop and maintain Sonder's regulatory strategy and roadmap supporting future diagnostic products, clinical validation, and commercialization initiatives.
Monitor evolving FDA, CLIA, CAP, and other applicable regulatory requirements, providing regulatory guidance across research, laboratory operations, clinical development, and platform development.
Support regulatory planning for laboratory-developed tests (LDTs), in vitro diagnostics (IVDs), companion diagnostics, regulatory submissions, and agency interactions.
Collaborate with Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership to translate regulatory requirements into practical business processes.
Serve as a trusted advisor by providing regulatory and quality expertise supporting strategic partnerships, commercialization initiatives, and organizational decision-making.
Establish scalable regulatory and quality capabilities that support Sonder's continued growth and evolving business needs.
Identify opportunities to strengthen organizational processes while recommending future regulatory and quality capabilities as the company advances toward commercialization.