Medical Device Compliance Manager
6 days ago
Job Overview:
About UsWe are a small team dedicated to bringing innovative solutions to the field of dental radiology. Our mission is to bring CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.
We are looking for a Regulatory Affairs Quality Specialist to join our team. As a Regulatory Affairs Quality Specialist, you will be responsible for ensuring that our medical devices comply with regulatory requirements.
The ideal candidate will have experience working with QA/QC for medical devices and a strong understanding of the main standards governing medical device development and production, such as MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 60601.
You will work closely with our cross-functional teams to ensure that our products meet the highest quality and regulatory standards.
We offer a dynamic and globally oriented business environment, experienced and skilled colleagues, and the chance to influence the future of dental imaging.
Key Responsibilities
- Develop and implement quality systems to ensure compliance with regulations and standards
- Coordinate internal audits and reviews to ensure continuous improvement
- Collaborate with cross-functional teams to identify and address potential quality issues
- Ensure that all product releases are fully documented and compliant with regulatory requirements
Desirable Skills
- M.Sc. degree or higher, preferably within biomedical or electrical engineering
- Experience working with QA/QC for medical devices
- Documented expertise in main standards governing medical device development and production
- Excellent communication and documentation skills - English at business level
- Excellent at creating and maintaining cross-functional working relationships
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