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.
Qualifications:
- 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.