- חסוי -
* Preparation of a regulatory plan / strategy for product development and approval as
well as maintenance of the product life cycle.
* Construct and file submissions in different regions (US, EU, Israel, LATAM, and more)
* Work closely with a consultancy law firm.
* Work closely with R&D, QA and marketing departments.
• Support design and development changes from a regulatory perspective
• Perform gap analysis on new laws / guidelines / regulations / standards and update
* Experience working with FDA (510k)/CE regulatory submissions and requirements-
* experience in chemical registration with EPA- must have
* Product development experience - high priority
* MDR implementation experience is an advantage.
* Ability to effectively manage multiple projects and priorities.
* English- Native language
* Ability to work under pressure and in tight schedules.
* self-motivated; ability to work independently, attention to details.
* Master's degree in science with more than 5 years of experience in regulatory
affairs in the / medical devices / Pharmaceutical / Biomed /Chemical industry
* Immediate availability for beginning employment