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International Medical Device Registration Manager
Vor 5 Tagen
We are currently looking for a highly organised individual with passion to join and strengthen our Market Access & Marketing team (which already covers English, Japanese, Mandarin and Spanish by native speakers)
Tasks
- Compile, edit and update international registration dossiers based on existing EU technical documentation for class I to III medical devices in English and Mandarin
- Maintain existing certification/approvals
- Research into national-specific regulations for product entry (product, QMS, etc)
- Research into reimbursement and procurement procedures
- Cooperation with various specialist departments within the company
- Regulatory point of contact for distributors, local authorisation holder and health authorities
- Support the creation of marketing materials that comply with regulatory standards
- Support in events planning
Qualification
- Fluent in English and Mandarin
- Min. B1 in German language
- Experience in the medical device sector
- Holds min. a bachelor's degree in medical technology/natural sciences/business
- Experience/knowledge in basic regulatory affairs for medical devices (preferred)
- Experience working in an international team
- Located in “StädteRegion Aachen”
We Offer You
• Collaboration in cross-functional and global teams
• An open and international working environment in a global family-owned company
• Continuous training opportunities
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