Compliance Specialist
21 hours ago
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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