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ALTEN MéxicoPosted 1 month ago

Regulatory Affairs Specialist – NMPA China (all gender)

HybridMannheim, Baden-Wurttemberg, Germany

Full TimeMid LevelEnterprise

Job Summary

Create and revise approval documentation for medical devices in China (NMPA), ensuring compliance with GB standards and adapting technical documents accordingly. Lead GAP analyses between EU MDR and Chinese requirements, coordinating the NMPA approval process including e-submission and regulatory authority coordination. Collaborate closely with local partners and international project teams to manage the regulatory lifecycle. This role requires a degree in Life Sciences or Medicine Technology with practical NMPA experience and strong English skills for structured international teamwork.

Required Qualifications

  • Studium in Life Sciences, Medizintechnik, Pharmazie oder vergleichbar
  • Erfahrung im Regulatory Affairs Umfeld für Medizinprodukte
  • praktische Erfahrung mit dem chinesischen Zulassungssystem (NMPA)
  • Kenntnisse zu EU MDR, China-Regularien und idealerweise GB-Standards
  • sehr gut Englisch
  • strukturiert in internationalen Teams

Desired Qualifications

  • GB-Standards

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