98303 - Senior Regulatory Affairs and QA Specialist - Medical Equipment

Mô tả Công việc

- 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>

• 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.

• Liaise with MOH to ensure products are approved for sale as soon as possible

• Responsible for sub-labeling, advertising, and promotion activities for regulatory compliance

• Responsible for post-market surveillance activities i.e.… Complaint report, FSCA (Financial Sector Conduct Authority), recall, etc.…

• Ensure product compliance for tender business.

• Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for regulatory, tender application, and sales

• Provide regulatory support in tender submission and corresponding inquiry as required

• Assess regulatory needs for pre- and post-marketing submission

• Input and update the global database and system as required

• Deliver the training of processes, procedures, and work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function

• Participate in the prediction of the effect of changes in regulations, policies, or procedure

• Coordinate with other departments i.e. supply chain, and business unit to support product availability on the market.

• Responsible for internal and external audits such as audits from suppliers or audits to distributors.

• Assists in any ad hoc tasks as required