Note: Fluent ~ Native level Japanese required, 医療機器薬事業務経験、ビジネス英語力必須
Summary of Position
- The Regulatory Affairs Specialist shall fulfill the required roles of a Class 1 Medical Device company by the supervision of marketing, manufacturing, and release of the product with the roles of (1) General Manager; (2) Post-Marketing Safety Controller; and (3) Quality Assurance Controller as required by the Japanese regulatory regulations. The Regulatory Affairs Specialist will prepare and submit all documents to register the full line of the Group products in Japan. The Regulatory Affairs Specialist is responsible for all aspects related to regulatory requirements specific to medical devices in Japan and to make sure that the company is in compliance with the relevant regulations.
- The Regulatory Affairs Specialist is responsible for providing guidance on medical device regulatory requirements as it relates to our Group products, including developing regulatory strategic plans in accordance with Japanese regulatory requirements.
- Implement and maintain the Quality Management System (QMS) as directed from the Director in US, Global Quality Assurance that complies with the Pharmaceuticals and Medical Devices Act (PMD Act) and the Ministry of Health, Labor and Welfare (MHLW) Ordinance #169 in Japan. (Based on ISO 13485).
- Fulfill the required roles of a Class 1 Medical Device company by the supervision of marketing, manufacturing and release of the product (1) General Manager; (2) Post-Marketing Safety Controller; and (3) Quality Assurance Controller as required by the Japanese regulatory regulations.
- Maintain and ensure that our Japan office have the necessary licenses and certifications to operate business in Japan and proper attention must be taken to renew any license well before the expiry date.
- Register new products with the PMDA regulatory authorities and make the necessary changes to current registrations as required.
- Provide HQ with the relevant product regulatory information, descriptions, pricing and other such information so that the team in US can register the product into SAP and follow up to make sure that all information is entered into SAP correctly
- Work with our 3PL to oversee the import and inspection of the products and approve products that pass the incoming inspection and reject products that have failed inspection and take the necessary procedures to dispose or return the products that have failed the incoming inspection to HQ in a timely manner.
- Work closely with our Japan leadership in the development of regulatory strategies to ensure consistency with the business objectives, including identification and analysis of the regulatory risks on the impact of the business and mitigations of the risks.
- Maintain regulatory files and tracking databases to ensure prompt and accurate access to regulatory information and provide reports to Management concerning current, pending, and future registration activities.
- Completed the educational and technical requirements as specified by the Japanese authorities in order to be qualified to fulfill the 3 roles required for a Class 1 regulatory position.
- International regulatory affairs experience in the medical device or related industry is mandatory, with a minimum of 3-5 years of experience.
- Advanced - Native level Japanese and Business level English
- Knowledge of Japanese regulations and guidance that affect medical device
- The ability to work in small team environment is essential. Must also be a self-starter with the ability to work independently.
- Must be able to work on problems of a diverse scope where analysis of a situation or data requires the evaluation of various factors.
- Strong technical, analytical, and problem-solving skills, including strong project management skills.
- Ability to communicate complex ideas clearly and simply, orally and inwriting.
- Ability to raise issues with colleagues and managers in a proactive, professional manner and drive win win outcomes.
- Must be proficient with Microsoft Office, including Word and Excel.
- The ability to travel is required.