Accountabilities: Develop Operation Team strategies to support the achievement of the company's objectives and goals. Lead, manage, and coach the Operations and Administration team to implement operational strategies, plans, and work procedures. Oversee regulatory affairs, purchasing, importation, inventory management , administrative functions, and operational support for Sales and Service teams. Manage medical device product registrations , import permits, and product amendments to ensure regulatory compliance. Monitor local and overseas purchasing activities and represent management in supplier negotiations. Ensure procurement, shipment, warehousing, storage, and distribution processes are carried out efficiently. Monitor logistics providers to ensure timely and safe delivery of goods and handle claims for lost or damaged shipments. Identify and maintain cost-effective third-party logistics and delivery solutions. Ensure invoices are issued accurately and comply with company requirements. Manage inventory levels to meet customer demand while minimizing inventory costs. Oversee operational support for the Service team, including Preventive Maintenance (PM) contracts and claim processes. Control petty cash usage within the Operations department. Continuously improve operational processes and implement changes to enhance efficiency and support company goals. Monitor and control operational expenses. Lead the company's Quality Management System (ISO 13485, ISO 9001) and ensure regulatory compliance. Drive operational excellence through KPI management, process optimization, SOP development, audits , CAPA, and risk management. Lead continuous improvement initiatives to reduce costs, improve customer satisfaction, and enhance operational effectiveness across Regulatory Affairs, Procurement, Logistics, Inventory Management, Customer Service, and Administration. Develop high-performing teams through coaching, training, and performance management. Manage supplier qualification and performance programs while supporting leadership with operational analysis, business reporting, budgeting, and strategic planning. Qualification: Bachelor's degree in Science or a related field. Minimum 5 years of experience in Operations within an international company, or at least 3 years of experience in Regulatory Affairs for Medical Device products. Experience in medical device, healthcare, life science, or related industries is highly preferred. Strong knowledge of regulatory affairs, purchasing, import/export processes, inventory management, logistics, and operational administration. Excellent command of English in speaking, writing, reading, and listening. Strong leadership, coaching, people management, and decision-making skills. Excellent planning, coordination, organizational, and problem-solving abilities. Strong interpersonal and communication skills with the ability to collaborate across departments. Able to work under pressure, manage multiple priorities, and meet deadlines with high accuracy. Mature, proactive, service-minded, self-motivated, and possesses high integrity.
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