Medical Device Regulatory Affairs Manager

20 hours ago


Malmo, Skåne, Sweden Magle Chemoswed AB Full time

Magle Chemoswed AB is expanding its regulatory team and seeking a skilled Regulatory Affairs Specialist to support our medical devices business. As a key member of the team, you will be responsible for ensuring compliance with regulatory standards and guidelines applicable in our active markets.

Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with international regulations.
  • Prepare and submit regulatory documentation required for approval and registration of new and existing products.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met.
  • Stay up-to-date on regulatory developments and changes to ensure compliance.
  • Provide training and guidance to colleagues on regulatory requirements.
Requirements:
  • 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 and project management skills.


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