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. Position Overview 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. Key Responsibilities Regulatory Affairs Strategy & Leadership 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. Quality Management Systems 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. Regulatory & Quality Operations Integrate Regulatory and Quality requirements into research, laboratory operations, clinical development, product development, and future commercialization activities. Support laboratory Quality initiatives and future CLIA/CAP readiness while ensuring Regulatory and Quality considerations are incorporated early into scientific and operational initiatives. Establish and maintain processes and documentation that provide evidence of Regulatory and Quality compliance and organizational readiness. Cross-Functional Leadership Partner with Research, Clinical Development, Laboratory Operations, Manufacturing, AI, Software Engineering, and Executive Leadership to translate Regulatory and Quality requirements into practical development and business processes. Serve as Sonder's internal Regulatory Affairs and Quality resource, providing clear guidance to multidisciplinary teams and helping drive implementation of required actions. Provide Regulatory and Quality expertise supporting strategic partnerships, clinical initiatives, commercialization planning, and organizational decision-making. Organizational Development Identify gaps in existing Regulatory and Quality capabilities, recommend priorities, and personally drive implementation of practical solutions. Recommend future internal capabilities, external expertise, and resources needed as Sonder's Regulatory and Quality requirements evolve Required Qualifications Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or a related scientific or technical discipline. 5–8+ years of progressive Regulatory Affairs experience within biotechnology, diagnostics, medical devices, pharmaceuticals, or another regulated life sciences environment, including meaningful experience with regulatory submissions, agency interactions, or related regulatory activities. Demonstrated experience developing or contributing to regulatory strategies, plans, or pathways, with working knowledge of FDA regulations and applicable regulatory requirements. Hands‑on experience with Quality Management Systems, including SOP governance, document control, and Quality processes such as CAPA, change control, training, or audit readiness. Strong project management, communication, judgment, and cross‑functional collaboration skills, with the ability to translate Regulatory and Quality requirements into practical processes. Ability to operate effectively in a hands‑on, fast‑paced, growth‑stage biotechnology environment with evolving Regulatory and Quality needs. Preferred Qualifications Experience supporting molecular diagnostics, in vitro diagnostics (IVDs), companion diagnostics, pathology, digital pathology, or AI-enabled healthcare technologies. Familiarity with CLIA, CAP, ISO 13485, and laboratory Quality systems. Direct experience with FDA submissions, regulatory agency interactions, or regulatory planning for diagnostic products. Experience building or expanding Regulatory Affairs and Quality capabilities within a startup or growth‑stage organization; relevant professional certifications such as RAC, CQA, or CMQ/OE are a plus. Success in the First 12 Months The successful candidate will establish the regulatory and quality foundation needed to support Sonder's continued growth by: Developing and advancing a scalable regulatory strategy and roadmap aligned with Sonder's clinical validation, diagnostic development, regulatory readiness, and commercialization objectives. Establishing clear regulatory pathways, requirements, priorities, and decision points for future diagnostic products, including LDTs, IVDs, and companion diagnostic opportunities as applicable. Advancing regulatory readiness by coordinating submission and agency planning, identifying regulatory risks and evidence needs, and engaging specialized external expertise when appropriate. Taking internal ownership of Sonder's Quality Management System (QMS) and strengthening practical, sustainable processes for SOP governance, document control, training, CAPA, and change control. Improving organizational readiness for FDA, CLIA, CAP, and future Regulatory and Quality inspections while integrating Regulatory and Quality considerations into scientific, clinical, laboratory, and product development activities. Establishing scalable Regulatory Affairs capabilities and strengthening Quality infrastructure to support Sonder's continued scientific, clinical, and commercial growth. What we offer Competitive compensation and meaningful equity opportunity, commensurate with seniority and experience. Medical, Dental, Vision, and other ancillary benefits 401k Plan Professional Development Impactful work at the forefront of early cancer detection, with direct influence on core technical strategy. High ownership and visibility, working closely with scientific and executive leadership. A collaborative, multidisciplinary environment. #J-18808-Ljbffr Initial Therapeutics, Inc.