Experience: Atleast three years as Qualified Safety Management Supervisor Responsibilities: ? To keep the Quality Management System (QMS) updated and compliant with internal guidelines and global standards with regards to the scope and points mentioned by you in trailing mail. ? If this role also requires global reporting, then add support global and domestic post-market surveillance (PMS) activities to ensure product safety and timely reporting ? Domestic PMS activities including reporting to regulatory authorities ? Assist with internal and external audits to ensure adherence to respective standards and regulations ? Manage controlled QMS documentation including SOPs, manuals, and procedures ? Investigate product issues such as complaints and non-conformances, and determine appropriate corrective actions or reporting ? Prior experience with QMS implementation and knowledge of Ordinance No.169 and ISO 13485 ? Work closely with MAH and distributor/cross functional teams. Language: Japanese (JLPT N2) + English (CET 2)