Quality Assurance and Regulatory Affairs Specialist

Quality Assurance and Regulatory Affairs Specialist

Sonologi

About Sonologi

Sonologi Inc. is a medical technology company advancing wearable ultrasound imaging for proactive disease monitoring and personalized care. Our platform combines miniaturized ultrasound electronics, wearable bioadhesive transducer systems, and software to enable hands-free visualization of deep anatomical structures, including cardiac, pulmonary, and vascular regions. The technology is built upon foundational research from the Massachusetts Institute of Technology.

Our vision is to help shift healthcare from reactive intervention toward proactive, data-driven disease management through accessible and scalable wearable imaging technologies.

The Role

We are seeking a hands-on, detail-oriented Quality Assurance and Regulatory Affairs Specialist to support Sonologi's wearable ultrasound program as it advances through design verification, clinical evaluation, and FDA 510(k) submission. The position combines quality-system execution with regulatory submission support and requires close collaboration with engineering, software, clinical, regulatory, and external laboratory partners.

The ideal candidate has 3–5 years of medical-device QA/RA experience and can independently organize documentation, coordinate cross-functional deliverables, and keep regulatory, clinical, usability, and laboratory testing activities aligned with project timelines.

Quality Assurance and Design Controls

• Support implementation and maintenance of the quality management system in accordance with ISO 13485 and applicable FDA Quality System requirements
• Maintain the Design History File and support design-control activities, including design plans, design reviews, requirements traceability, risk management, verification and validation, and design changes
• Draft, revise, and control SOPs, work instructions, forms, and quality records; support document control, training, CAPA, nonconformance, supplier quality, and internal audit activities as needed
• Support preparation and maintenance of the Risk Management File in accordance with ISO 14971 and ensure risk controls are linked to verification, usability, clinical, and labeling evidence

Regulatory Affairs and FDA Submission Support

• Support FDA 510(k) and Pre-Submission (Q-Sub) activities, including preparation of briefing materials, FDA questions, meeting records, eSTAR content, and responses to agency requests
• Assist in developing and maintaining the regulatory strategy, submission plan, device description, indications for use, labeling, predicate comparison, and performance-testing summaries
• Coordinate regulatory inputs from engineering, software, clinical, human factors, biocompatibility, and testing teams and ensure consistency across submission documents
• Monitor relevant FDA guidance, recognized consensus standards, and regulatory requirements and translate them into actionable project deliverables
• Maintain alignment among product claims, risk-management records, verification and validation evidence, clinical data, and submission content

Usability and Human Factors Engineering

• Support usability and human factors engineering activities in accordance with IEC 62366-1 and relevant FDA guidance
• Coordinate use-related risk analysis, user profiles, use environments, task analysis, critical-task identification, user-interface requirements, and the Usability Engineering File
• Assist in planning, executing, documenting, and following up on formative evaluations and human factors validation studies, including protocol development, participant coordination, data review, and final reports

Clinical Study Coordination

• Support planning and management of clinical feasibility and performance studies, including protocol and case…