Regulatory Affairs and Quality Assurance Assistant

About the role

About the Role: We are looking for a motivated and detail-oriented Regulatory Affairs and Quality Assurance Assistant to join our RA/QA team in an international, cross-cultural environment. This role requires a high level of proficiency in both English and Japanese, as you will act as a key communication bridge between our European office and headquarters in Japan. Responsibilities include interpreting during meetings, translating documents, and preparing professional documentation in Japanese. The position reports directly to the RA/QA Manager and works closely with internal teams and headquarters in Japan. No prior experience in Regulatory Affairs is required. Full training will be provided. Candidates with a scientific or life sciences background are encouraged to apply. Key Responsibilities: 1. Regulatory Affairs Support - Provide general support to the RA/QA team - Assist in MDR (Medical Device Regulation) related activities - Assist in preparation and maintenance of Technical Documentation (TD) - Contribute to CE certification activities for new and legacy devices - Support data collection, analysis, and documentation for regulatory purposes - Monitor regulatory updates and summarize key changes 2. Bilingual Communication (English-Japanese) - Translate documents and communications between European office and headquarters in Japan - Interpret during meetings with headquarters and support real-time communication - Create and maintain documentation both in Japanese and English, including reports, summaries, and internal materials - Prepare meeting minutes, summaries, and follow-up reports in English and/or Japanese as required - Facilitate clear and effective communication between European teams and headquarters 3. Documentation & Data Maintenance - Maintain regulatory data, ensuring accuracy and completeness - Support the collection and maintenance of regulatory and quality-related data - Assist with protocol and documentation management - Maintain organized records in compliance with regulatory requirements 4. Operational Support - Assist the RA/QA team with local regulatory registrations and compliance tasks - Support QA activities and ongoing quality projects, including Quality Management System (QMS) maintenance - Respond to inquiries from clients, distributors, and other external stakeholders - Contribute to process improvements and workflow organization 5. Cross-functional & Team Support - Provide support to team members during absences or peak workload periods - Assist with product vigilance reporting and logistics (e.g., device returns) - Collaborate across departments to ensure smooth operations 6. Learning & Development - Develop and maintain knowledge of European Medical Device Regulation (MDR) and other applicable regulatory requirements. Profile & Requirements: Essential - Native-level Japanese and professional working proficiency in English (spoken and written) - Ability to translate and interpret accurately in a business environment - Strong communication and interpersonal skills - Excellent attention to detail and organizational skills - Proactive, adaptable, and eager to learn Preferred (Nice to Have) - Experience with documentation, translation, or administrative roles - Background in life sciences, biomedical engineering, pharmacy, medical technology, or related field Flexible work options: Hybrid working model Supportive team environment: A culture that values collaboration, learning, and high performance Competitive benefits: Attractive pension scheme, bonus scheme, and 3-4 additional end-of-year holidays in addition to 24 vacation days Well-being perks: Sports/gym subscription allowance Company culture: Friday drinks, kick-off outings, and an end-of-year dinner to connect with colleagues

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