DNA Diagnostic A/S, Risskov
Do you have experience with Regulatory Affairs, CE-marking and quality management within ISO 13485 medical equipment or in vitro diagnostic devices, then this is the opportunity for you!
You will be a part of the cross-functional QA team working closely with the sales and production teams. You will be the RA/QA expert within specific products, and will work on compliance with the ISO 13485 standard. The responsibilities will be within the following fields:
- Maintenance and expansion of ISO 13485 quality system
- QC approval of production documents
- Development of device master record and other documents for product registration