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With a global experience in medical devices regulatory, compliance and clinical affairs, Andaman Medical is trusted partner across Southeast Asia. Strategically positioned throughout Southeast Asia - Singapore, Malaysia, Indonesia, Philippines, Thailand and Vietnam), we facilitate manufacturers from USA, Canada, Europe, ANZ, Japan, Korea, China to reach the ASEAN market and beyond, focusing on intricate regulatory differences between global regulations and diligently following local procedures and updates. Andaman Medical services for Medical Devices and Healthcare include: - Regulatory Intelligence - Clinical Evaluation - Product Registration & Establishment Licensing - Quality Management Systems (ISO 13485, US FDA 21 CFR part 820, GDPMD) - Business Services - Auditing, Training & Support Andaman Medical provides a complete range of services for all Quality, Regulatory and Clinical needs for South East Asia submissions. Our methodology brings time and financial efficiency for compliance-related issues with regulatory requirements. In addition to stream-lining your submission process, we offer expert training in all phases of the development and regulatory process. We are always looking for bright, energetic people who would like to advance their career in the medical device regulatory industry

Công Ty Tnhh Andaman Medical Việt Nam Tuyển Dụng

Regulatory Affairs Executive

Nhân viên
Thỏa thuận / tháng
yêu cầu giới tínhKhông yêu cầu
ngành nghềY tế - Dược, Hóa học - Sinh học
địa điểmHà Nội
hình thức làm việcToàn thời gian cố định
yêu cầu bằng cấpKhông yêu cầu
Position Overview
This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Consultant is expected to drive best practices in office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.
Essential Job Functions
Regulatory
• Prepare submissions to the local health authorities for new product registration
• Follow-up input request from the authorities to ensure successful product registration
• Maintain company databases of regulatory approvals
• Ensure complianace with relevant local regulations and internal policies.
• Having good relationship with authorities - Ministry of Health (as preferred).
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