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Responsible for all regulatory affairs activities worldwide. Assures regulatory submission compliance for submissions. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions. Responsible for designing, implementing, and maintaining an effective quality system. Reports the performance of the quality system to relevant authorities and Company Management as required.
• 2+ years’ experience as a RA/QA specialist.
• Scientific degree.
• Extensive knowledge & experience of international medical device regulations and guidelines
• Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
• Excellent analytical abilities
• Full working proficiency in English
• Able to write reports and business correspondence.
• Proficient in Microsoft Office including Excel, PowerPoint and MS Project.
• Possesses and applies problem-solving skills.
• Able to work with details and complete assignments with minimal supervision.
• Very high communication, presentation and customer-service skills.