勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
給料 Negotiatable
参照番号 39044


A Japanese manufacturer of premium quality needles and cannulas for the global aesthetic market. 



  • Responding to audits, inspections, and conformity surveys by domestic and foreign regulatory authorities, certification bodies, and customers.

  • Management of audit, inspection and conformity assessment plans.

  • Responding to inquiries from customers, overseas offices, and suppliers regarding quality and laws and regulations

  • Management and supervision of quality assurance, safety control and regulatory compliance operations

  • Management representative (QMS Management Representative) as required by the ISO, FDA/QSR and ・QMS Organization Ordinance

  • Maintenance and management of the quality management system

  • Handling general QA principles like change control, CAPA, Complaints

  • Contribute to internal audit

  • Supplier management (new suppliers) and audit of Japanese suppliers

  • Oversee manufacturing records and QC testing

  • Work related to compliance with regulations in various countries, including development of regulatory strategies.

  • Public relations with domestic and foreign regulatory authorities and certification bodies



  • More than 3 years of practical experience in QA work at medical devices company or pharmaceutical company.

  • Experience in Japan domestic RA or/and MDR RA

  • Experience working as a general marketing supervisor of medical devices and/or Domestic quality assurance manager.(Plus)

  • Management representative (QMS Management Representative) as required by the ISO 13485, FDA/QSR.(Plus)

  • Knowledge of the Pharmaceutical and Medical Device Act, ISO 13485, and other laws and regulations of each country

  • Business level of English and Japanese