International Medical Device Registration Manager

Vor 5 Tagen


Aachen, Deutschland DynaMesh® - FEG Textiltechnik Vollzeit

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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