Experience

FEMSelect

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• VP Quality & Regulatory

  • May 2021 - Present

  Manage Regulatory Affairs & Quality Management Activities. Manage Regulatory Affairs & Quality Management Activities.



MedicSense (IQVIA)

• Petach Tikva, Israel

• Senior Regulatory Consultant

  • Jun 2010 - Present

  As project manager, I'm responsible for the QA\RA activities at several Medical Device companies. The key activities I routinely perform include: Establishment & implementation of Quality Management Systems’ according to EN/ISO 13485 & FDA 21 CFR 820. Maintenance & continual update of company's quality management systems to affirm compliance with national & international requirements (e.g. EU, FDA-QSR, Canada-MDR, Israel, ISO 13485). Continuous follow-up & maintenance of Quality Management System procedures and demonstration of their effectiveness. Ensuring products & labeling comply with all regulatory requirements (national & international). Establishing & maintaining Technical Files & Design History Dossiers. Customer Complaint handling and Vigilance Reporting. Subcontractors and Suppliers evaluation and approval. Leading internal and external audits. Show less



Mavrik Dental Systems®

• United States
• Medical Device
• 1 - 100 Employee

• QA\RA Director (Part Time)

  • Mar 2016 - May 2021

  Manage regulatory affairs & quality management activities. Manage regulatory affairs & quality management activities.



Motorika - Robotic Rehabilitation Solutions

• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA\RA Director (part time)

  • Nov 2010 - Mar 2016

  Responsible for all Regulatory & Quality Management activities. Managed, lead and maintained the organization’s certification to ISO 13458 and CE mark, FDA product approval. Created & maintained DMRs', Technical Files', DHF's & DHR's. Trained employees, lead Risk Management activities &performed internal & external audits. Responsible for all Regulatory & Quality Management activities. Managed, lead and maintained the organization’s certification to ISO 13458 and CE mark, FDA product approval. Created & maintained DMRs', Technical Files', DHF's & DHR's. Trained employees, lead Risk Management activities &performed internal & external audits.



R.M.T. Raphael Medical Technologies Ltd.

• Caesarea, Israel

• VP Quality Management

  • Sep 2003 - Jun 2010

  Managed, lead and maintained the organization’s certification to ISO 13458 and CE mark, involved in product FDA Approval. Active member of Management Team. Prepared the DMR. Maintained and updated the Technical File. Compiled and lead experiments. Carried out Process Validation, Training, Clean Room Control, and Risk Management. Managed, lead and maintained the organization’s certification to ISO 13458 and CE mark, involved in product FDA Approval. Active member of Management Team. Prepared the DMR. Maintained and updated the Technical File. Compiled and lead experiments. Carried out Process Validation, Training, Clean Room Control, and Risk Management.



SGS

• Switzerland
• Professional Services
• 700 & Above Employee

• Certification Manager

  • 2000 - 2002

  I served as Certification Manager (the authority for approving company ISO 9001 certification). My position included Operational Management of the certification department. I Carried out certification audits according to ISO 9001 & ISO 13485 standards. I Supervised 8 employees, 6 of them lead auditors. I served as Certification Manager (the authority for approving company ISO 9001 certification). My position included Operational Management of the certification department. I Carried out certification audits according to ISO 9001 & ISO 13485 standards. I Supervised 8 employees, 6 of them lead auditors.



Filtration Ltd.

• Quality Manager

  • 1993 - 1999

  • Managed, lead and maintained the organization’s ISO 9001 certification and CE mark. • Composed and implemented quality and plant procedures. • Improved work methods (Production, Logistics, Procurement and Engineering). • Supervised the function of service layout locally and abroad worldwide. • Managed, lead and maintained the organization’s ISO 9001 certification and CE mark. • Composed and implemented quality and plant procedures. • Improved work methods (Production, Logistics, Procurement and Engineering). • Supervised the function of service layout locally and abroad worldwide.