Regulatory Compliance Specialist

24 hours ago


Malmo, Skåne, Sweden Magle Chemoswed AB Full time

Magle Group is a dynamic and growing company in the Life Science industry, providing CDMO services and developing products with DSM technology. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory standards and guidelines applicable in our active markets.

Key Responsibilities:
  • Prepare and submit regulatory documentation required for approval and registration of new and existing products in international markets.
  • Stay updated on regulatory procedures and changes to ensure compliance and advise the company on necessary adjustments.
  • Legalize registration documentation and maintain regulatory files.
  • Inform and educate the organization on submission requirements and provide necessary documents.
  • Update regulatory authorizations and maintain registrations, renewals, device listings, site registrations, supplements, and annual reports.
  • Respond to questions from regulatory authorities and handle recalls and field actions.
Qualifications:
  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum 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 and ability to interact effectively at all levels of the organization.


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