Smart Solution

אודותינו

20 years’ experience of increasing responsibility and leadership in organizations directly related to Quality Management, Clinical and Regulatory Affairs FDA (QSR) / ISO 13485 / MEDDEV 2.7/1 requirements in High-Tech, Medical Device, and Bio-Tech industries.
In many challenging environments I have been called upon to provide leadership and guidance to business partners and team members. My educational background includes Master Degree in Reliability Engineering & Applied Statistics Science as well as MBA from NY University (NYU) international / pharmaceutical concentration.
I would welcome the opportunity to provide possible "best fit" QA/RA consulting / subcontractor services.

שפות

אנגלית

שפת אם

רוסית

שפת אם

עברית

שליטה קרובה לשפת אם

תחומי התמחות

בכירים

300 ₪ לשעה

סמנכ"ל אבטחת איכות

20 years’ experience of increasing responsibility and leadership in organizations directly related to Quality Management, Clinical and Regulatory Affairs FDA (QSR) / ISO 13485 / MEDDEV 2.7/1 requirements in High-Tech, Medical Device, and Bio-Tech industries.
In many challenging environments I have been called upon to provide leadership and guidance to business partners and team members. My educational background includes Master Degree in Reliability Engineering & Applied Statistics Science as well as MBA from NY University (NYU) international / pharmaceutical concentration

נסיון תעסוקתי

היום

Senior Executive FDA Consultant (Israel, EU and Russia area districts)

U.S , FOOD & DRUG ADMINISTRATION (FDA)

היום

Design Control Subcontractor

Biosense Webster J&J , Israel

2015 - 2018

Director QA/RA

CMT MEDICAL - THALES

Responsible for Quality / Regulatory and Clinical compliance for Israel Subsidiary

2010 - 2015

VP QA/RA

VENUS CONCEPT

Responsible for WW Quality / Regulatory and Clinical compliance for the company businesses across Israel, Canada and Spain sites.

2007 - 2010

QA/RA Director Six Sigma MBB

COLBAR LIFESCIENCE LTD- J&J SUBSIDIARY

Responsible for all Quality and Regulatory Complaince for the ColBar LifeScience, J&J Subsidiary. Led management reviews at the Executive Board Level, ensuring the Quality System is appropriately resourced and functioned efficiently. Recruited, developed and managed a team of 40 associates (QA, RA, Validation, QC, and Documentation Control groups). Aligned quality and regulatory initiatives with Corporate J&J business objectives. Provided quality / regulatory perspective to strategic planning of the long-range R&D projects. Interfaced with Global Regulatory Affairs functions to prepare registration documentation and PMA supplements on product design, manufacturing, and sterilization changes. Responsible for overall Risk Management, Customer Complaint Handling, Customer Service, Post-Market Surveillance processes. Deployed Operational Excellence processes to improve manufacturing efficiency, reduce product cost, and identify opportunities for continual improvement

2002 - 2007

Corporate QA Manager / Six Sigma & Reliability Expert

BECTON AND DICKINSON & CO , US

Responsible for Corporate Quality Compliance within the Diabetes Care Segment. Sales are 1.2 billion per year. The products line is comprised of Insulin delivery products and Blood Glucose Monitoring equipment.