International Medical Device Registration Specialist

Vor 6 Tagen

Aachen, Nordrhein-Westfalen, Deutschland DynaMesh® - FEG Textiltechnik Vollzeit

We are seeking a highly organized and detail-oriented individual to join our Market Access & Marketing team at DynaMesh® - FEG Textiltechnik. As a key member of our team, you will play a crucial role in ensuring the compliance of our medical devices with international regulations.

Key Responsibilities:

  • 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 and approvals.
  • Research national-specific regulations for product entry, including product, QMS, and other relevant aspects.
  • Research reimbursement and procurement procedures.
  • Collaborate with various specialist departments within the company.
  • Act as the regulatory point of contact for distributors, local authorization holders, and health authorities.
  • Support the creation of marketing materials that comply with regulatory standards.
  • Assist in events planning.

Requirements:

  • Fluent in English and Mandarin.
  • Minimum B1 in German language.
  • Experience in the medical device sector.
  • Holds a minimum of a bachelor's degree in medical technology, natural sciences, or business.
  • Experience or knowledge in basic regulatory affairs for medical devices is preferred.
  • Experience working in an international team.
  • Located in the StädteRegion Aachen area.

We Offer:


• 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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