Amsterdam, North Holland, Netherlands · Hybrid
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 leve…
Skills: Japanese Proficiency, English Proficiency, Translation, Interpretation, Regulatory Affairs
Amsterdam, North Holland, Netherlands · Hybrid
THE MISSION As a Product Manager, you will work closely with the Marketing department on the development and promotion of our Peripheral Intervention medical device range. You will be involved in every stage of product m…
Skills: Product Marketing, Market Research, Competitive Analysis, Clinical Education, KOL Management
Amsterdam, North Holland, Netherlands • Hybrid
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The role involves providing regulatory and quality assurance support, specifically assisting with MDR activities and technical documentation. Additionally, the assistant serves as a bilingual bridge, translating and interpreting between the European office and the Japanese headquarters.
Candidates must have native-level Japanese and professional English proficiency with strong communication and organizational skills. A background in life sciences or a related scientific field is preferred, though no prior regulatory experience is required.
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
Medical device manufacturer specialised in super fine stainless steel products
Asahi Intecc is a Japanese medical device company specializing in the development and manufacture of innovative products for cardiovascular, peripheral, radiology, and neurovascular fields. Our products are designed to meet physicians’ needs and help improve patient outcomes. Asahi Intecc Europe B.V., the European headquarters of the Asahi Intecc Group, established its physical presence in Europe in 2004. Asahi Intecc Europe office address: Strawinskylaan 1461 (WTC Tower Ten - 14th floor), 1077 XX Amsterdam, The Netherlands
Offices: Strawinskylaan 1461, WTC Tower Ten - 14th floor, Amsterdam, North Holland 1077 XX, NL
Medical device manufacturer specialised in super fine stainless steel products
Asahi Intecc is a Japanese medical device company specializing in the development and manufacture of innovative products for cardiovascular, peripheral, radiology, and neurovascular fields. Our products are designed to meet physicians’ needs and help improve patient outcomes. Asahi Intecc Europe B.V., the European headquarters of the Asahi Intecc Group, established its physical presence in Europe in 2004. Asahi Intecc Europe office address: Strawinskylaan 1461 (WTC Tower Ten - 14th floor), 1077 XX Amsterdam, The Netherlands
Offices: Strawinskylaan 1461, WTC Tower Ten - 14th floor, Amsterdam, North Holland 1077 XX, NL
