Compliance and Regulatory Expert

3 days ago


Malmo, Skåne, Sweden Magle Group - Malmö Full time

As a key member of our regulatory team, you will be responsible for preparing and submitting regulatory documentation required for the approval and registration of new and existing products in various international markets.

You will stay updated on regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on necessary adjustments. Additionally, you will maintain regulatory files and update regulatory authorizations, such as Investigational Device Exemptions (IDEs), 510(k) submissions, Canadian medical device licenses, and CE dossiers for the EU, as well as NRTL certifications.



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