Responsible for product registration, variation, and renewal.
Assist in establishing and maintaining a quality management system in compliance with ISO 13485 and Indonesia CPAKB requirements, ensuring that system documentation meets registration and regulatory inspection requirements.
Responsible for post-market surveillance of products, including adverse event reporting, product recalls, and field safety corrective actions, and maintain compliant communication with regulatory authorities.
Work closely with technical, production, and quality departments to ensure that product design changes, labeling, and instructions for use comply with registration requirements.
Establish and maintain good relationships with the Indonesian Ministry of Health, medical device regulatory authorities, customs, and inspection and quarantine agencies; support local audits and ensure timely updates on regulatory policies
Requirements :
Bachelor's degree or above in Pharmacy; CPAKB certification is preferred.
Fluent English in listening, speaking, reading, and writing.
At least 3 years of experience in medical device regulatory registration, with strong knowledge of Indonesia's medical device registration processes and regulatory framework.
Familiar with ISO 13485, MDR, FDA, and related standards.
Good communication skills, with the ability to effectively engage with government officials and maintain strong relationships.
