Regulatory Compliance Specialist

2 weeks ago


Middelfart Kommune, Denmark Demant Polska Full time

At Demant Polska, we are seeking a highly skilled Regulatory Compliance Specialist to join our Global Quality Department in Middelfart. As a key member of our team, you will play a vital role in ensuring compliance with regulatory standards for medical device development.

Key Responsibilities:
  • Provide regulatory support and assistance to internal stakeholders
  • Ensure Technical Documentation (STED file) is prepared for all products and handed over to the Homologation Team
  • Create, review, and maintain regulatory documentation and labelling
  • Support registration in Eudamed, FDA database, and GUDID

You will work closely with our Vice President of Global Quality, Diagnostics, to ensure that our products meet the highest regulatory standards. If you have experience in a similar position in an international company and strong knowledge of ISO 13485 and MDR 2017/745, we encourage you to apply.



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