Regulatory Professional/ Regulatory Affairs Specialist in Cystotech ApS 

Would you like to join a team of dedicated people committed to make a difference to cancer patients and assist us to gain regulatory approval for an innovative medical device improving patient care - and outcome from a global perspective?  

If this is the case, we are looking to recruit a Regulatory and Quality Specialist and expand our team.   

Cystotech ApS is an Aarhus-based MedTech company developing software as a medical device for AI-detection and categorizing of urinary bladder cancer. The Company is a spin-out from Aarhus University Hospital founded in October 2021.  

As we are developing a medical device, ensuring compliance according to the regulatory frameworks and ISO 13485:2016 has a high priority for the company. 

As an QA/RA-Specialist in Cystotech, you will be part of a highly dedicated team still evolving and growing. You will gain in-depth insight into our QM System and your primary responsibility will be to assist in building and qualifying the QM System. You will work in accordance with the relevant standards and specific regulatory guidelines primarily in the EU and US.  

It is essential, that you are structured and interested in documentation processes, and can provide high-quality in your work. We expect that you will provide the team with regulatory input, are proactive, and take an active part in the discussions and interactions with both the team and the external regulatory advisors. 

Job Profile 

• Provide regulatory support by co-creating content for the QM System prior to ISO 13485/ MDR certification  

• Participate in the planning, execution, and follow-up on internal and external audits  

• Maintain the QM System 

• Participate in compliance training regarding Medical Device 

• Assist in developing FDA-compliant documentation  

• Participate in R&D projects covering Regulatory Affairs issues 

• Monitor legislation, and be able to translate and prepare implementation  

• Contribute to the process of market approvals  

Your interpersonal skills 

• Positive and pragmatic attitude 

• Open-minded 

• Self-driven 

• Good communication skills in English – both verbal and writing  

• Willingness to learn 

• Collaborative team-player 

Your experience/ education 

• A Bachelor or Master degree within a science or engineering field 

• Experience with quality management systems 

• Experience from working in a regulated industry - Medical Device development is an advantage 

• Documented training in relevant standards such as ISO 13485, ISO 14971, IEC 62304, IEC 62366 

We offer 

A full-time position (e.g., 37 hours per week), working primarily at our office in Aarhus. Remote work can be discussed.  

You will be working in a dynamic and positive work environment with a dedicated team and will have a key role in the buildup of our QMS structure.