Global Regulatory Affairs Specialist

4 days ago


Malmo, Skåne, Sweden Magle Chemoswed Full time

Join Our Team

Magle Group is a dynamic and growing Life Science Company seeking an experienced Global Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and experience working with medical devices.

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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