Global Regulatory Affairs Professional

10 hours ago


Malmo, Skåne, Sweden Magle Group Full time

At Magle Group, we believe in making an impact by improving lives for patients worldwide. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and support our medical devices business.

This role will involve preparing and submitting regulatory documentation required for approval and registration in various international markets, as well as maintaining regulatory files and updating regulatory authorizations. The ideal candidate will have a strong understanding of international regulatory guidelines and standards, as well as excellent communication skills.

  • Key Responsibilities:
  • Preparation and submission of regulatory documentation for new and existing products.
  • Maintenance of regulatory files and update of regulatory authorizations.
  • Response to questions from regulatory authorities.
  • Assessment of device-related incidents and complaints for medical device reporting requirements.

Qualifications:

  • 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.
  • Proven track record in preparing successful regulatory submissions.
  • Excellent communication skills.


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