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)