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המימד השלישי גיוס והשמה

מומחה רגולציה


לחברה מובילה בתחומה דרוש/ה Regulatory Affairs Engineer/Specialist
במסגרת תפקידו:
• Develop regulatory strategy for submissions of new products and changes to existing products
• Support, prepare and coordinate regulatory submissions of new products or changes to existing products. 
• Prepare and maintain technical files and general safety and performance requirements
• Coordinate and communicate activities with external consultants and regulatory bodies
• Review DHF documentation to assure compliance with regulatory requirements.
• Review and interpret regulatory requirements during product development and communicate to the project team 
• Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions
• Support Risk Management activities
• Create, update and maintain standards list
• Support manufacturing activities 
• Provide requirements for, review and approve product labelling
• Support compliant handling

דרישות התפקיד

Minimum Qualifications:
• B.S. degree in Life Sciences or equivalent
• 3+ years of experience in regulatory submissions of new products to regulatory agencies
• Excellent written and verbal communication skills, including proficiency in medical terminology from several disciplines
• Strong multitasking ability with impeccable attention to details.

כישורים נדרשים