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RA Manager

neoLaser / משרה חלקית


שתף משרה:
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• Support ongoing RA activities including distributor registrations in various countries, addition of product lines, support/update of ongoing certification etc
• Involvement and assistance in strategic registrations in key countries (FDA, PMDA, CE others)
• Handling of AMAR registration and certification
• Guidance and involvement in core QA activities (Risk Management, Clinical Evaluation, PMS)
• Support the CEO with regulatory and quality related topics
• Support external audits as they relate to RA/QA topics
• Review and update quality procedures as they relate to regulatory requirements of various geographies
50-60% employment
• Bachelor’s level education in relevant domain, academic excellence a plus
• At least 3 years of relevant and meaningful experience in a RA and/or QA role (managerial or not) in a ISO13485 certified company that is manufacturing/shipping products. Previous RA experience a plus
• Track record of quality audits and international registrations of medical devices a plus
• Excellent speaking and writing English skills
• Detail oriented with very strong analytical, logical and writing skills a must
• Can-do attitude, resourceful, and able to work independently
• Excellent interpersonal and team skills
• Problem solving skills, creative thinking