Japan Market Access Manager [Aachen]

FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH based in Aachen (Germany) develops and produces textile medical products that are sold worldwide under the protected brand name DynaMesh®. We are an ISO 13485:2016 and MDR certified company and currently employ over 75 people.

We are currently looking for a highly organised individual with passion to bring our mesh implant into the Japanese market to join and strengthen our international Market Access team (which already covers English, Spanish and Chinese by native speakers)

Japan Market Access Manager

Tasks
• Editing/updating of the technical documentation for class I to III medical devices in English and Japanese
• Compilation of dossiers for Japanese PMDA approvals
• Research into Japanese national regulations for product and QMS certification/approval and maintaining certification/approval
• GAP analysis between MHLW and MDR
• Research into reimbursement and procurement procedures in Japan
• Cooperation with various specialist departments

Qualification
• Fluent in English and Japanese
• Business efficiency in German – B2 level and above (preferred)
• Completed bachelor's degree in medical technology or natural sciences or training in a medical or pharmaceutical assistant profession (preferred)
• Experiences/basic knowledge and understanding in regulatory affairs
• Experience in/knowledge about Japan health care environment – including reimbursement and health care economics (preferred)
• Good overall communication skills

We Offer You
• Collaboration in cross-functional and global teams
• An open and international working environment in a global family company
• Home office options
• Continuous training opportunities

Are you interested? We look forward to hearing from you.
Please email your CV to Arielle Obolenski (bewerbung.ma@dyna-mesh.com)