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.
Key Responsibilities
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 report form development, site and investigator coordination, IRB submissions, study-startup activities, participant tracking, data collection, and study closeout
- Track study milestones, protocol deviations, adverse events, data queries, and required records and help maintain complete, inspection-ready clinical documentation
- Work with clinical and regulatory advisors to ensure that study endpoints and evidence support the intended use, device claims, risk-management conclusions, and FDA submission strategy
External Laboratory Testing Management
- Plan and coordinate third-party testing for electrical safety, EMC, ultrasound acoustic output and performance, biocompatibility, software, and other applicable verification activities
- Prepare test-submission packages, device configurations, block diagrams, safety-critical component lists, test plans, samples, and supporting technical documentation
- Serve as a primary point of contact with external laboratories; manage quotations, schedules, sample shipment, test readiness, technical questions, deviations, failures, retesting, and final-report review
- Track laboratory deliverables against the project schedule and ensure final reports are accurate, complete, and suitable for inclusion in the FDA submission
Required Qualifications
- Bachelor's degree in engineering, life sciences, regulatory affairs, quality assurance, or a related field
- 3–5 years of combined quality assurance and regulatory affairs experience in the medical-device industry
- Practical experience supporting FDA medical-device submissions, preferably a 510(k), and working with FDA guidance and recognized consensus standards
- Experience with medical-device design controls, ISO 13485 quality systems, ISO 14971 risk management, and regulated document control
- Experience supporting usability and human factors engineering activities, including IEC 62366-1 documentation and usability study coordination
- Experience coordinating or managing clinical studies, including protocols, IRB interactions, study sites, data collection, and study documentation
- Experience managing external compliance laboratories and reviewing test plans and reports
- Strong project-management, technical-writing, communication, and organizational skills, with the ability to manage multiple workstreams in a startup environment
Preferred Experience
- Experience with diagnostic ultrasound, medical imaging, wearable devices, digital health, or cardiac monitoring
- Working knowledge of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62359, and the ISO 10993 series
- Experience with software-enabled medical devices, cybersecurity documentation, or mobile medical applications
- Experience supporting FDA inspections, internal audits, supplier audits, or QMS implementation in an early-stage company
- Experience using electronic document-management or project-management tools such as Smartsheet, Jira, or an eQMS
How to Apply
Please send your resume and a brief cover letter describing your most relevant quality, regulatory, human factors, clinical study, and laboratory-testing experience to: info@bcicglobal.org