Regulatory Affair

Job Overview
This Senior Regulatory Affairs position requires a high level of autonomy to support the achievement of regulatory goals and objectives. It encompasses both Vietnam market Operations Support and Office Coordination to facilitate daily business operations. The role is designed to drive best practices in office and administrative management, maximizing efficiency and growth. The primary responsibility is to support regulatory submissions for clients and to develop and maintain comprehensive regulatory knowledge.
Main Responsibilities:
Provide Vietnam operations support as a director of the site, facilitating daily business operations.
Investigate whether health products require medical device registration, determine risk classification, and establish the submission route.
Prepare and submit documents related to initial, renewal, variation/change notifications of medical devices, and follow up until approval.
Notify manufacturers promptly of feedback from authorities to ensure successful product registration.
Respond to customer regulatory concerns and maintain a regulatory database.
Conduct research to prepare regulatory intelligence reports on relevant topics.
Monitor emerging regulatory trends to assess potential impacts on internal projects, and draft regulatory updates for internal communication.
Assist the sales team with regulatory discussions when required.
Develop and maintain Standard Operating Procedures, working practices, and regulatory policies to ensure compliance is maintained or enhanced.
Liaise with external parties regarding regulatory requirements.
Report post-marketing activities such as mandatory problem reporting, field safety corrective actions, recalls, and other regulatory obligations.
Ensure awareness and compliance with regulatory and statutory requirements throughout the organization and its supply chain.

discussion

English, Regulatory Affairs