About us
Cebreo Medical A/S in Allerød is an innovative medical device company pioneering a new category of wearables to collect medical-grade EEG and valuable brain health insights day and night.
Today quality and regulatory management are mainly handled externally. But as our organization grows, we wish to strengthen our internal quality function to secure continued compliance with global standards. This position is a key part of that effort.
About the role
You will have a key role in ensuring the area is developing along with our business and bring the best practices across our organization.
If you are motivated by impact, ownership, and ensuring robust systems, this opportunity will allow you to make a significant difference for a rapid growing organization.
Key responsibilities:
- Develop and maintain Cebreo Medical’s Quality Management System (QMS) to ensure full compliance with ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
- Plan, coordinate, and lead both internal and external audits, including FDA inspections and Notified Body audits.
- Oversee risk management activities in line with ISO 14971 by establishing risk management plans and monitoring progress.
- Drive our complaints/deviations, change management, CAPA and continuous improvement processes
- Collaborate closely with R&D, software, and manufacturing teams to ensure that design, technical documentation, and production controls comply with regulatory requirements while also ensuring the processes are efficient and aligned with the R&D team way of working.
- Collecting, reviewing, and maintaining technical files to support regulatory submissions.
Your professional skills
We design and manufacture class I and II medical devices. You will be working independently in the daily with mainly the above-mentioned key responsibilities.
To thrive and success in the position the following competences are therefore essential:
- A technical degree (B.Sc. or M.Sc.) in Engineering, Life Sciences, or a related field.
- Professional experience in a similar role within a company developing and manufacturing Class II medical devices.
- Proven track record with regulatory submissions of Class II medical devices in the EU and US.
- Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR regulatory frameworks.
- Familiarity with ISO 14971 and the application of risk management principles to medical devices.
Your Soft Skills:
It is deeply rooted in our DNA that we work closely together across the various professional areas in our organization.
We have constant focus on a pragmatic and proactive approach to our way of working and not least: Having in mind not to complicate things unnecessarily.
We weigh your personal characteristics just as much as your professional skills. To succeed with us and to be the strongest possible support to your future colleagues, the following personal characteristics are paramount:
- Ability to set bar at the right level – not too high nor too low.
- Meeting your colleagues with an open and welcoming attitude ready to support them with your strong knowledge as the Subject Matter Expert in your field.
- A will to merge into our working culture keeping in mind that your approach, expertise and ideas will directly shape our path forward.
Want to know more?
If you have any questions regarding the position, please reach out to Director of Operations Maria Agdrup Hüche on email: maah@cebreomedical.com. Recruiter Tine Cranil, mobile 2072-8822 assists us throughout the recruitment process.
Additional info
Cebreo Medical A/S is a Danish medtech company based in Allerød that works with EEG (measuring the brain's electrical activity) and develops technology for continuous brain monitoring. Cebreo has developed Cebreo NeuroBuds—ear-based wearables that resemble standard earbuds but are capable of recording medical-grade EEG. The aim is to make EEG measurements far more natural and less intrusive than traditional EEG equipment.
We are 30 employees, and as we are small our culture is characterized by being agile and with a strong collaborative culture.
We offer a competitive salary, a good working environment, and regular staff events. We look forward to welcoming you to the team!
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