1. Responsible for quality systems and regulatory compliance to ensure process and product conformance to Japan regulations and the company requirements.
2. Responsible for maintaining and/or enhancing existing Quality functional systems in compliance with MHLW Ordinance requirements including but not limited to Ordinance 87, 94, 135, 169 in a manner that effectively supports growth for the company.
3. Responsible to coordinate and maintain product approvals, reimbursement registration, and business licenses in Japan on a timely manner.
4. Provides leadership and consulting services related to Japan regulations including Japanese Pharmaceutical Affairs Law and different MHLW ordinances; as well as assist during audits from Japanese government to the company’s manufacturing facilities and the Japan offices.
5. Responsible to maintain proper and timely communication with Japan regulatory authorities and notified bodies as needed; as well as to provide adequate information of the products as required by the regulatory offices.
6. Responsible to communicate to the Global in a timely manner of any potential product quality issues informed to the Japan office and coordinate with other QARA team members adequate investigations and corrective actions.
7. Responsible to coordinate with the Regulatory Affairs team of the Global any potential field action activity involved in the Japanese market for the Japan products.
8. As a key contributor to the Health Care organization, the incumbent is expected to understand the company’s business needs and serve as a key link between Japan and the Global offices and the business teams, suppliers and contract manufacturers impacting Japan market.
・A broad technical background, preferably a graduate level degree, or as a minimum, a bachelor’s degree in a science or engineering discipline, plus ten or more years of managerial experience in Quality or Regulatory Affairs as well as experience in establishing and managing compliance programs for medical devices and/or pharmaceuticals in the Japanese market.
・Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions, and an in-depth knowledge and application of relevant domestic and international regulations.
・General knowledge of Regulatory requirements as:
・Japan Pharmaceutical Affairs Law
・Several MHLW Ordinances (i.e. 87, 94, 135, 136, 169)
・USA Regulations (21 Code of Federal Regulation, FDA Guidelines, QSIT, etc.)
・European Regulation (ISO 9001, ISO 13485, ISO 14971, and others)
・General knowledge in contamination control practices for the Japanese market
・Root Cause analysis and failure investigation tools
就業時間:9 時00 分～17 時45 分 ※フレックス制度あり