Regulatory Affairs Specialist - Ho Chi Minh

Job description
We Are Looking for Applicants Residing in Vietnam.
Andaman Medical is a young and fast-growing Medical Device Regulatory Affairs & Market Access consultancy. We specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia. Our clients are among the world's leading Medical Device and IVD Manufacturers. Our dedicated experts are located in various SEA countries including Malaysia, Singapore, Thailand, Philippines, Vietnam, Cambodia and Indonesia.
Job Overview
This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Regulatory Affairs Specialist 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
•Investigating whether the Health Product is a medical device requiring registration with authority, determining its risk classification, grouping and its route of submission.
•Carry out application related to the Product Registration on behalf of Company by preparing necessary documents such as Common Submission Dossier Template (CSDT).
•Preparing and submitting documents related to Initial, Renewal, Variations/Change Notification of medical devices and other regulatory submissions.
•Constantly follow up with the Authority on submitted application until approval process.
•Promptly inform manufacturer is there's any feedback from Authority to ensure successful product registration.
•Communicating with customers in respond to their regulatory concerns.
•Maintain regulatory database for the Company.
•Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
•Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and handles the drafting of the regulatory update article that will be provided to the Marketing team.
•Assist sales team in discussion with client on regulatory related matters (when required).
•Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
•Liaising with external parties on matters relating to Vietnam medical device regulatory requirements.
•Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
•Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.