Regulatory Affairs Executive

Biosensors Interventional Technologies Pte Ltd; Jakarta Utara; On-site; IDR 300.000.000 - 400.000.000; Full time

Job summary

A leading medical technology company in Jakarta Utara is seeking a qualified individual to ensure the safety and quality of medical devices. The role involves developing a quality management system, approving products, and managing storage compliance. Suitable candidates will have a degree in Pharmacy and at least 3-5 years of relevant experience in medical device distribution and quality management.

Qualifications

• Minimum 3-5 years of work experience in understanding the regulations on distribution of medical devices.

Responsibilities

• Develop and maintain the CDAKB quality management system.
• Prepare training programs on CDAKB for personnel.
• Approve or reject finished products.
• Monitor medical device storage and analysis.
• Assist in handling complaints about quality.

Skills

Good communication and collaboration

Knowledge of Quality Management System

High level of integrity

Education

Diploma or Bachelor degree in Pharmacy

Job description

Ensure the distribution system runs well to ensure the safety, quality and benefits of distributed medical devices.

Responsibilities

• Develop, ensure and maintain the implementation of the CDAKB quality management system
• Prepare and / or approve basic training programs and further training on CDAKB for all personnel involved in distribution activities
• Accompany the audit team of the Ministry of Health and coordinate actions / responses to the findings.
• To support external auditors and coordinate actions / responses to the findings.
• Ensuring the fulfillment of technical requirements or regulations of the Ministry of Health related to the quality of the product.
• Approve or reject the finished product for sale taking into account all related factors.
• Evaluate and authorize all written procedures and other documents, relating to / impacting on product quality, including amendments.
• Responsible for monitoring and environmental control of medical devices.
• Establish and monitor the implementation of hygiene / sanitation / cleanliness in the warehouse
• Evaluate the protocol and qualification / validation reports as well as approve / authorize them together with the relevant sections.
• Provide approval and monitoring of medical device storage and analysis under contract.
• Authorizing the application and together with the Warehouse to monitor the storage conditions of the product.
• Determine and supervise the implementation of the record keeping system of all activities.
• Monitoring the fulfillment of CDAKB requirements.
• Assist in the handling of all complaints about quality, carry out the recall of medical devices and review all changes related to systems, documents, products, buildings and supporting facilities.
• Conduct product quality assessment (PMP) according to the schedule set.

Requirements

• Diploma or Bachelor degree in Pharmacy, and / or other equivalent personnel according to the product being distributed
• Minimum 3-5 years of work experience in understanding the regulations on distribution of medical devices
• Good communication and collaboration techniques to build cross function and support
• High level of integrity
• Knowledge of Quality Management System

Biosensors International Group is a leading manufacturer and supplier of cardiovascular stents globally, committed to investing in and developing pioneering medical technology, pharmacological research, and engineering new medical devices.