Amirul Bahry Email & Phone Number

Singapore

Assist in implementing and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485:2016 and other relevant regulatory standards.Participated in the first production audit, contributing to the successful expansion of the production scope in the organization’s ISO certification.Support in maintaining up-to-date documentation and.

Singapore, Singapore

• Coordinated with regulatory authorities, including the Health Sciences Authority (HSA) Singapore, Medical Device Authority (MDA) Malaysia, and the Ministry of Health Indonesia, ensuring timely approval and compliance.
• Managed the end-to-end process of regulatory submissions, meticulously handling documentation for medical device approvals, product registrations, change notifications, and license renewals to meet stringent regulatory.
• Compiled ASEAN Common Submission Dossier Template (CSDT) documentation for suppliers and manufacturers in strict accordance with the regulations stipulated by respective health authorities.
• Managed and tracked product registrations across Singapore, Malaysia, and Indonesia, ensuring compliance with regulatory standards for successful market entry.

Singapore

• Carried out syringe-filling and packaging operations daily for shipment and storage
• Collaborated with technical and supervisory personnel to report for defects or resolve conditions affecting safety, efficiency and product quality
• Achieved production targets by maintaining high productivity levels and communicating with team members regarding orders and fulfillment.
• Liaised with internal teams to complete project design, production, research, process flows and documentation.

Singapore

• Managed Safety Induction training programme for contractors to reinforce their workplace safety and health awareness on sites.
• Executed successful industrial hygiene programs based on techniques such as indoor and outdoor air sampling to provide ongoing worker support.
• Maintained documentation of daily notes, safety training records and accident investigations

Graduate Certificate In Medical Device Regulatory Affairs, Medical Device Regulatory Affairs

Activities and Societies: - Overview of US & EU Medical Device Regulation; - Routes to US market for medical devices; - Routes to CE.

Diploma Of Education, Chemical Engineering

Activities and Societies: Student Chapter- Designed a course representative logo for Singapore Polytechnic, Chemical Engineering.