Job Description
<Main tasks> - Monitoring legal trends: + Collecting and analyzing new or amended legal documents related to medical devices in Vietnam, including laws, decrees, circulars and decisions. + Building and updating the database of legal documents. - Standard impact assessment: + Assessing the impact of new legal documents on the company's business operations, product registration and market access. + Summarizing key points of standard changes and reporting to relevant departments. - Compliance and implementation support: + Coordinating with departments such as QA/QC, R&D, Production Management to ensure legal compliance. + Drafting internal regulations and SOPs (Standard Operating Procedures) based on the law. - Document inspection and reporting: Conducting inspection and accurate storage of legal documents, licenses, approval documents. - Training and Internal support: + Organize and conduct internal training courses on standard requirements. + Support the assessment of legal risks related to product registration, labeling and market activities.
Job Requirement
<Required Skills/Experience> ・Education: University degree in Law, Pharmacy, Public Health or equivalent. ・Foreign languages: Japanese - Good communication (Good drafting and communication skills, including legal and technical terminology) Or English - Good communication - Experience (3 years or more) in the legal, regulatory or regulatory compliance fields in the medical device or healthcare industry. - Understanding of the Vietnamese legal system and regulations related to healthcare. - Good research, analysis and communication skills. <Skills> ・Understanding of medical device regulations or international standards (e.g. ISO 13485, MDR). ・Ability to organize and manage multiple Legal Regulation projects simultaneously.