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.



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 Senior Regulatory affairs position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. It has Inter Country Operations Support and Office Coordinator Role that Facilitates Daily Business Operations Activities of AMV.This position is expected to drive best practices in office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.
 
Main Responsibilities:
•To provide inter country support, as an acting director of site that helps facilitate daily business operations activities of Vietnam Site.
•Investigating whether the Health Product is a medical device requiring registration with
• MOH, determining its risk classification and its route of submission.
• Preparing and submitting documents related to Initial, Renewal, Variations/Change
• Notification of medical devices, follow-up 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 providing and drafting regulatory updates to Marketing Manager.
• 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’s 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.




Job requirements


Qualifications
• At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology,
• Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as pharmacist/apothecary in Vietnam eligible to become Director in Vietnam Site.
• At least 4 years’ experience in the medical device industry and especially in regulatory
 
Key Competencies
• Expert on country regulations with excellent client communication skills both verbal and in writing.
• Excellent project management skills.
• Good team management skills.
• Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
• Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc..)• At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move.
• Able to operate in a multicultural environment.
• High level of autonomy at work, yet with profound team-spirit