Compliance Specialist

3 days ago


Copenhagen, Copenhagen, Denmark Demant Polska Full time

Our Team:

We are a dynamic and inclusive team committed to creating an environment that fosters growth, learning, and innovation. As a Compliance Specialist, you will be part of a team of 12 dedicated professionals working together to ensure the quality and safety of our medical devices.

Responsibilities:
  • Ensure the compliance of our medical devices with ISO 13485 and MDR regulations.
  • Develop and maintain quality management systems and procedures to ensure compliance with regulatory requirements.
  • Conduct internal audits and CAPA investigations to identify and correct non-conformities.
  • Collaborate with cross-functional teams to develop and maintain technical documentation.
  • Provide training and support to colleagues on quality management systems and procedures.
Requirements:

To be successful in this role, you should have a minimum of 3 years' experience working in quality assurance or a related field. You should possess a strong understanding of ISO 13485 and MDR regulations, as well as excellent communication and problem-solving skills.

You will work closely with our team in Poland and Denmark to ensure seamless collaboration and effective quality management.



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