Cerebriu’s vision is to simplify radiology to improve patient journeys, starting within neuroradiology. We focus on improving clinical workflow, faster scans producing right data, triage acute patients to focus on the right patients, and improve accuracy and confidence to make the right decision.
We are looking for a Regulatory Affairs Specialist who would like to join us to develop our development & quality processes and quality management system to support agile development and certification of future Apollo releases together with the cross functional development team here in Copenhagen.
At Cerebriu we give you the opportunity to work with state-of-the-art medical devices based on AI solutions to transform radiology.
We expect you will be working on the following:
· Certification of Apollo under MDR and in turn FDA regulations.
· Continued development, monitoring, and improvement of our ISO-13485:2016 compliant QMS and development processes.
· Post-market surveillance, CAPAs, and customer feedback
· Product and process quality control, measurement, and analysis.
A relevant technical degree at the BSc/MSc level and documented experience with QA-work within the SaMD space ideally in combinator with relevant certified education.
We are looking for experience in
· Development and maintenance of QMSs according to ISO-138485:2016 and MDD/MDR, and FDA regulations.
· Quality assurance in relationship to SaMD development
· Processes related to clinical validation of SaMDs in accordance with MDD/MDR and FDA regulations.
Actual experience with certification of SaMDs at the European and/or US level is not expected but would be extremely relevant.
You are fluent in English both verbal and written and maintaining good relationships with all stakeholders/third-party vendors is important to you. You can take direction and work in a self-directed manner in a collaborative team environment.
This job comes with several perks and benefits
Enjoy a free catered lunch with your colleagues, every day.
Time is precious. Make it count. Morning person or night owl, this job is for you.
Get your caffeine fix to get you started and keep you going.
Easy access and treehugger friendly workplace.
Social gatherings and games; hang out with your colleagues.
Break a leg! Seriously, we got you covered in our company healthcare plan.