Associate Manager, Regulatory Affairs - Medical Devices

Associate Manager, Regulatory Affairs - Medical Devices

About the Company : This company is a rapidly growing multinational organization specializing in the distribution and sale of diagnostic instruments and medical devices. Their products play a critical role in diagnostic testing and are essential to the healthcare ecosystem. With well-established operations in Malaysia, the company continues to strengthen its presence and is now focused on expanding its footprint across the region in a sustainable and strategic manner.

About the Job : In this role, you will lead the Quality Assurance and Regulatory Affairs (QRA) function. You will oversee regulatory and quality activities to ensure compliance with local and regional requirements. You will also work closely with internal teams and regulatory authorities to support the company’s growth through strong compliance and quality systems.

Job Responsibilities :

• Oversee product registrations, business licenses, and certifications to ensure compliance with regulatory requirements.
• Lead audits and quality initiatives to maintain and improve quality management systems.
• Monitor regulatory updates and handle compliance matters, including customer and product-related issues.
• Manage pharmacovigilance activities, including training and reporting, in line with local regulations.
• Collaborate with internal teams and stakeholders to drive continuous improvement and support business objectives.

Job Requirements :

What’s on offer :

Key Details

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