Device Registration and Compliance Professional

7 days ago


Malmo, Skåne, Sweden Magle Chemoswed Full time

Ensuring Regulatory Compliance

Magle Group is committed to ensuring regulatory compliance and seeks an experienced Device Registration and Compliance Professional. The successful candidate will have a strong understanding of international regulatory guidelines and standards.

Key Responsibilities:

  • Prepare and submit regulatory documentation required for the approval and registration of new and existing products in various international markets.
  • Stay up-to-date on regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on necessary adjustments.
  • Manage legalization of registration documentation and maintain regulatory files.
  • Inform and educate the organization on submission requirements and ensure necessary documents are provided.

Requirements:

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 5 years of experience in regulatory affairs, specifically with medical devices.
  • Strong understanding of international regulatory guidelines and standards such as FDA, CE Marking, ISO 13485, MDR, etc.


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