Responsibilities:

• Oversee the product registration and market access approval process in assigned countries, ensuring timely product registration. This includes managing the entire regulatory approval process until market launch, maintaining product registrations throughout its lifecycle, and handling any variations, license retention, and post-market regulatory tasks.
• Maintain an up-to-date registration database to ensure accurate record filing.
• Serve as the primary contact for local authorities and organizations to resolve regulatory compliance issues, stay informed on current and evolving regulations, clarify product lists, and align launch timelines.
• Support the QA/RA review, approval, escalation, impact analysis, and risk mitigation process for OHS-G New Product Launch initiatives and any product design changes initiated by HQ, regional teams, business partners, or regulatory agencies.
• Advise cross-functional teams on QA/RA matters and approve product literature, including translated instructions for use, marketing, labeling, and packaging, ensuring they meet regulatory standards.
• Manage regulatory assessments related to medical claims.
• Stay informed about changes in regulations and communicate these updates to internal stakeholders.
• Offer guidance on relevant regulatory documents and standards to both internal and external teams, and assist in training as needed.
• Support the development of country-specific regulatory frameworks to speed up market entry.
• Coordinate and facilitate the Quality Training Program, conducting periodic refresher courses to enhance employee skills and improve the quality management system's effectiveness.
• Participate in or support multi-functional teams and projects to ensure regulatory compliance in designated sales areas, assist with interpreting relevant regulations, and determine the appropriate regulatory pathways for various projects, including product classification and submission types.
• Manage and ensure the effectiveness of the OHS-G Quality Management System (QMS), overseeing its development, maintenance, improvement, and compliance.
• May serve as the Management Representative, Designated Person, Qualified Personnel, or Technical Person for the QMS.
• Develop, review, and approve Standard Operating Procedures (SOPs), Work Instructions, and other quality-related documents across departments.
• Lead and assist during internal and external audits, manage and resolve non-conformities, and coordinate corrective and preventive actions.
• Analyze complaints, assess their reportability, and participate in post-market surveillance activities as required.
• Manage quality-related supplier activities, including registration, evaluation, and providing recommendations for improvements in supplier quality management.

• A college degree in engineering, medicine, pharmacy, chemistry, biology, or medical equipment engineering is required to meet eligibility criteria for medical device trade establishments under Articles 40(1) and 41 of Decree No. 98/2021/ND-CP.
• A solid understanding of business processes and procedures related to Regulatory Affairs and Product Registration, as well as knowledge of the regulatory frameworks and requirements in the designated country(s) for medical devices.
• Familiarity with national regulations and requirements for regulatory approval and market access, including laws such as Telecommunication Regulations, Consumer/Industry Standards, and Environmental Regulations, is a plus but not a requirement.
• Basic knowledge of regional and international Medical Device Regulations and/or related international standards is advantageous but not required.
• Experience with audit principles and practices related to the Quality Management System (QMS) is beneficial, particularly if qualified as an internal auditor or lead auditor.
• Proficiency in English, both written and spoken.
• Strong skills in Microsoft Office applications (Word, Excel, Adobe, PowerPoint).