Regulatory Affairs Specialist (Medical Devices)Bayer Vietnam Limited (BVL)

Job Main Purpose:
In country Regulatory Affairs to support Bayer Radiology Vietnam business, focused on medical devices.
YOUR ROLE & RESPONSIBILITIES:
• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for Vietnam registrations for Bayer Radiology medical devices.
• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for Vietnam as per required timelines to the Global Regulatory Affairs teams.
• Review the labelling materials to ensure the compliance to local labelling requirements. Drive global, regional and local stakeholders for the labelling compliance to Vietnam regulatory requirements.
• Monitor and communicate the new or updated regulations from Vietnam, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of Vietnam are kept up to date in database systems.
• Develop and maintain tracking of regulatory activities, including submission prioritization, submission status tracking and submission dossier archiving.
• Support Regulatory device internal processes/SOP/KPI development and roll-out related to Vietnam regulatory activities.
• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advice from Vietnam regulatory standpoint.
• Work in close collaboration, ensuring prioritization, alignment and effective communication with APAC Device Regulatory Head, Vietnam RAD Commercial and Global Regulatory Affairs teams.
• Perform other appropriate duties as assigned by management to support the regional/local radiology business.