Registration and Quality Specialist

Описание

Main Responsibilities :

• Provide Quality support in Supplier Management process, assessment of suppliers based on Quality Assurance criteria, company quality policy, standards and local regulations
• Management of product complaints, timely reporting into local system, data trending.
• Handling Customer Complaints
• Perform registration and certification/declaration processes and work independently on each step from initialization till certificates obtained
• Documents Request from manufactures include working with manufacturers databases, share points or other manufacturers source
• Registration Dossier Preparation
• Review product registrations for accuracy and completeness of documentation is required
• Cooperation with local business
• Cooperation with out sours companies
• Responsible for accurate documentation of new products for submissions to authorities
• Ensure timely registration of all new products and obtaining of relevant licenses

Requirements:

• Higher education (Biomedical engineering education / background is an advantage)
• 2 + of experience in Regulatory Affairs in Medical Devices preferably
• Knowledge of legislation on registration of medical devices
• Knowledge of English language, sufficient for business communication purposes
• Result-oriented, initiative, proactive
• Team player
• Good communication (collaborative approach) and analytical skills, open-minded

Conditions:

• Competitive salary & annual bonus
• Medical insurance
• Mobile allowance
• Opportunities for professional development and growth