Compliance Specialist

21 hours ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Are you a motivated and detail-oriented professional looking for a new challenge? Do you have a passion for quality management and regulatory compliance? Look no further than Radiometer Danmark

We're seeking a QA/QMS Professional with Danish language skills to join our team as a Compliance Specialist - Quality Management Systems. In this role, you'll be responsible for ensuring our products meet the highest standards of quality and compliance.

The ideal candidate will have a strong background in quality management systems, with experience working within the medical device industry. Proficiency in Danish is essential, as well as excellent communication and stakeholder management skills.

Core Responsibilities:

  • Develop and maintain procedures for quality management
  • Conduct internal audits and assessments to ensure compliance
  • Collaborate with cross-functional teams to implement quality improvements
  • Ensure adherence to quality management systems and regulatory requirements

Desirable Qualifications:

  • MSc in Engineering, Pharmacy, Biology, Biochemistry or similar
  • Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
  • Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation)
  • Excellent communication and stakeholder management skills
  • Master spoken and written English and Danish language skills


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