Job Description

• Takes charge in products for assigned Regulatory Affairs tasks.
• Prepares and submits required regulatory applications for new products for replacement, change of manufacturing process.
• Monitors and submits regulatory applications for changes of approved products.
• Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
• Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
• Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc.
• Researches and consolidate regulatory requirements and communicate their information with supervisor and manager. 
• Supports in the development of best practices for Regulatory Affairs processes.
• Conforms regulatory compliance.
• A team player with a diligent and sincere attitude and mindset.
• Has a strong sense of responsibility on meeting due/target and quality/integrity/accuracy of the output.

Requirements

• A minimum Bachelor’s degree is required. 
• Minimum 2 years of RA experience in Healthcare industry
• Knowledge of regulatory environment, relative law and regulations on Medical Devices.
• Good at writing and translation skill in English

Interested parties please send your full resume with your current and expected salary to [email protected]