Sivan Elizarov

Member of a municipal parent leadership group and steering committee, supporting initiatives for families of children with special needs and collaborating with local stakeholders.

Supporting families in navigating healthcare, education, and social systems, providing guidance on rights-related processes (non-legal, non-clinical).

Supporting individuals facing mental health challenges, focusing on life skills, daily functioning, and system navigation.

Led SaMD-focused quality and design control activities for digital therapeutics products, serving as the primary quality point of contact for software development processes. Reviewed design control artifacts and supported alignment with IEC 62304 and IEC 62366.

Led and supported a supplier quality remediation program for pre-market products, focusing on quality control and procurement-related supplier quality requirements. Developed and maintained supplier qualification and control plans, ensuring components and suppliers met defined quality requirements.

Supported implementation and compliance of the Quality Management System (QMS) in accordance with ISO 13485, operating at QA Engineer Level II. Participated in CAPA, Non-Conformances, complaint investigations, and DFMEA activities.

Led Design Quality and Design Control activities for SaMD/SiMD products, ensuring compliance with internal procedures and applicable standards. Managed change control processes and maintained the Design History File (DHF).

Provided senior-level QA and compliance consulting to medical device companies, supporting establishment, enhancement, and maintenance of Quality Management Systems (QMS) in accordance with ISO 13485. Prepared organizations for external audits and certifications, and supported risk management and software lifecycle alignment.

Quality assurance specialist role supporting quality systems and compliance activities.

Medical project management and validation role supporting product development and quality processes.

Research assistant in the Stem Cell R&D Department, supporting research activities.

Provided non-clinical support to individuals facing mental health challenges, supporting daily functioning, life skills, and community integration within structured rehabilitation frameworks.

Activities and societies: Coursework includes machine learning applications in healthcare using Python, R, and SPSS.

Pursuing a Master of Public Health in Epidemiology with advanced training in epidemiological methods, applied statistics, and quantitative research for clinical and regulatory applications.

Member of the Regulatory Program for Medical Devices & Pharma, currently in progress.

Completed training as a Manual and Automated QA Tester.

Earned ISO 13485 Internal Auditor certification.

Earned ISO 13485 Lead Auditor certification.

Certified as a Professional AutoCAD user.

Completed training in Good Clinical Practice (GCP).

Earned a Bachelor of Science in Biotechnology Engineering, providing a strong foundation in engineering and life sciences.