RK

Rachel King

Regulatory Affairs Manager at 1MED SA

Rachel King has extensive experience in regulatory affairs within the medical device industry. Rachel has held various roles such as Regulatory Affairs Manager, Senior Regulatory Specialist, Regulatory Affairs Associate, and Regulatory Affairs Technician. In these positions, Rachel has been responsible for tasks such as submission and maintenance of Design Dossiers and Technical Files for medical device registration in the EU and the USA, sterilization validation, packaging validation, writing and maintaining QMS documentation, and providing regulatory input to CAPA activities. Rachel's experience also includes quality assistance and maintenance of Technical Files for medical devices. Rachel holds a degree in Biomedical Science from Cardiff University.

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Timeline

  • Regulatory Affairs Manager

    April, 2021 - present

  • Senior Regulatory Specialist

    February, 2020