DNA Diagnostic A/S is looking for a RA/QA Specialist for a maternity leave.
Do you have experience with Regulatory Affairs, IVDR-CE-marking and quality management within ISO 13485 medical equipment or in vitro diagnostic devices, then this is the opportunity for you!
Your primary tasks:
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
- Development and updating of technical documentation for CE marking (IVD 98/79 and IVDR 2017/746)
- Participation in development projects as an RA/QA expert
Expectations for the right candidate
You have a master’s degree within Life Science, preferably molecular biology, biochemistry or similar.
You are experienced working with ISO 13485.
Experience with regulatory approval of medical devices or in vitro diagnostic devices will be valued in the application. Experience with D4infonet as a quality system will be an advantage.
Personal skills include structure, drive and persistency – you work in a structured pragmatic way, and through cooperation you will find the right solutions. You also enjoy working independently, can manage and prioritize multiple tasks, and you are a fast learner who dives deeply into complex areas and creates an overview. You have a high proficiency in English – both written and verbally.
We offer you
- A job in a dynamic organization in Aarhus with an informal culture
- A position with many exiting challenges, and a position you can influence greatly
- A job in a market leading company within Biotech and qPCR technology
- The position is minimum 10 month maternity leave from 1.10.2025.
Who are we?
DNA Diagnostic A/S is a privately owned Danish Biotech company founded in 1992, specialized in the development of PCR and qPCR test kits for Covid-19, leukemia and food safety. Learn more at our website: www.dna-diagnostic.com or our LinkedIn page.
Application
Applications will continuously be reviewed, therefore apply as soon as possible.
If you have any questions related to this job, please contact CEO Anders Petersen,
+45 2235 7065 / Ap@dna-diagnostic.com
Apply with QuickApply on Jobindex.
https://www.jobindex.dk/ansoegninger/ny/2305741
