Neutron Indonesia is currently looking for experienced Regulatory Affairs Officer and Import Coordinator.
Neutron, with over 14-year experience serving clients worldwide, is specializing in Asia medical device. Recognized widely for our professional knowledge and management excellence, Neutron continues to offer the best solution to our clients.
Regulatory Affairs Officer
• Responsible for preparing the submission dossier to Ministry of Health and communicating with the principals regarding local regulatory requirements.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Maintaining the medical device license and post marketing report.
• Liaising and negotiating with regulatory authorities.
• Ensuring that quality standards and submission deadlines are met.
• Bachelor Degree in Engineering, Scientific, Health Care or related degree in reputable university
• Minimum 2 years of regulatory affairs experience in the pharmaceutical or medical device industry
• Fluent in English (oral and written) and ability in Chinese language will be an added advantage
• Responsible for handling the import process for medical device and preparing all import documents.
• Keep abreast of government issuances on customs clearance process and of technical issues for brokers.
• Consult with customs and all related government agencies.
• Maintain import license and other related company licenses to ensure smooth customs clearance process.
• Bachelor Degree in any field
• Minimum 2 years’ experience in export-import process for medical devices and health products
• Fluent in English (oral and written) ability in Chinese language will be an added advantage
Salary : to be discussed
Industry : Medical Device Trading
Company Size : 50 Employees
Language : English
Benefits : Medical, Bonus
Working Hours: Mondays-Fridays 8am – 5pm
HOW TO CONTACT US
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