- Working location: Dong Da District, Hanoi.
<Position Objective/Expectation >
The Senior RA and QA Specialist, who will be responsible for obtaining medical device pre- market regulatory approval to ensure market access is realized for product portfolio and service in the Vietnam market. Senior Officer RA/QA also will handle the sub- labeling, advertisement regulatory activities, and post- marketing regulatory activities i.e. complaint report,...
<Job Responsibilities>
• Liaise with MOH to ensure products are approved for sale as soon as possible
• Provide regulatory support in tender submission and corresponding inquiry as required
• Responsible for implementing and managing the regulatory activities of medical devices by MOH (Ministry Of Health) registration guidelines including new product submission, renewal submission, classification certificate, and variations submission.
• Assess regulatory needs for pre- and post- marketing submission
• Ensure product compliance for tender business.
• Deliver the training of processes, procedures, and work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function
• Responsible for sub- labeling, advertising, and promotion activities for regulatory compliance
• Coordinate with other departments i.e. supply chain, and business unit to support product availability on the market.
• Participate in the prediction of the effect of changes in regulations, policies, or procedure
• Responsible for internal and external audits such as audits from suppliers or audits to distributors.
• Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for regulatory, tender application, and sales
• Responsible for post- market surveillance activities i.e.… Complaint report, FSCA (Financial Sector Conduct Authority), recall, etc.…
• Input and update the global database and system as required
• Assists in any ad hoc tasks as required
