Experience

Nucleai

• United States
• Software Development
• 1 - 100 Employee

• Head of Regulatory Affairs and Quality Assurance

  • Jun 2022 - Present



DarioHealth

• United States
• Wellness and Fitness Services
• 200 - 300 Employee

• Director QA / RA

  • Jan 2022 - Jun 2022



MaxQ Artificial Intelligence (AI)

• Israel
• Medical Device
• 1 - 100 Employee

• Director of Quality and Clinical Affairs

  • Nov 2019 - Jan 2022

• Manager, Quality and Clinical Affairs

  • Mar 2018 - Nov 2019

  Establishment and full implementation of the company’s Quality Management Systems (QMS). Risk-based design of QMS processes to comply with internal and external requirements - Risk Management, Training, Management Review, Design Controls, Change Control, Document Control, CAPA, Complaint Handling, Post Marketing Surveillance, Supplier Qualification and Monitoring, Internal Audits, Production Controls. Lead company audits (Notified Bodies, suppliers qualification, FDA Excellence Appraisal, internal)Support Clinical Studies’ planning, set up and conduct (protocol, CRO, site selection/qualification, monitoring, and reports).Compliance – CE (MDD/MDR), FDA (Digital Health SW Precertification Pilot) , ISO 13485, IEC 62304, ISO 14971, ICH GCP Show less



Dot Compliance

• United States
• Software Development
• 100 - 200 Employee

• Senior Consultant

  • Nov 2015 - Feb 2018

  Consulting organizations on QMS establishment - risk-based mapping of processes and interactions, SOP writing, training and implementation of controls. Consulting software development team on regulatory compliance and industry best practices. Consulting organizations on QMS establishment - risk-based mapping of processes and interactions, SOP writing, training and implementation of controls. Consulting software development team on regulatory compliance and industry best practices.



DOT Consulting Ltd.

• Israel
• Information Services

• Project Manager

  • Sep 2012 - Feb 2018

  Project management in local and global pharmaceutical, medical device and biotechnology companies (e.g. Omrix, NeuroDerm) within a range of departments: R&D, Clinical, Regulatory Affairs, QA and more. Consulting key stakeholders on management of complex processes within the organizations - scope definition, timeline evaluation, risk identification and assessment, resource allocation and more; while also overseeing cross-functional alignment and administrative support. Planning as well as executing multi-disciplinary efforts e.g. Clinical Supply, Indication Expansion Launch, Quality Management Systems establishment, compliance gap analysis. Show less



Tiltan Pharma

• Israel
• Biotechnology

• VP Regulatory Affairs

  • 2004 - Sep 2011

  Leading regulatory submissions for Clinical Study initiation and progress (FDA IND, Israeli MOH, Medical Centers IRB/EC). Document writing and consultants' management for Clinical, Pre-Clinical and CMC sections. Clinical study management – document writing (Study Protocol, IB, Informed Consent Form, CRF, Clinical Study Report), site selection, CRO selection and management, site set-up (initiation meetings, staff training), Clinical Supply, site monitoring (CRA), quality control, data management. Proactive involvement with all Chemistry Manufacturing and Controls (CMC) activities – development, product and process specifications, stability studies, quality assurance, production scale-up, contract manufacturing setup, process validations, test method development and transfer, materials' supplier selection, packaging and labeling. Hands-on participation in all other aspects of Product Development i.e. pre-clinical studies, Supply Chain (transport, material supply, import), grant applications (e.g. Chief Scientist Office). Show less



Pharmaceutical division at Ministry of Health

• Web site manager

  • 2001 - 2005