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.
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
Good communication skills in English – both verbal and writing
Willingness to learn
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
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.
This job comes with several perks and benefits
Easy access and treehugger friendly workplace.
Social gatherings and games; hang out with your colleagues.
Time is precious. Make it count. Morning person or night owl, this job is for you.
We want to take you from good to great.
Your local office is your anchor point, thus, we placed it centrally at your convenience.
Get your caffeine fix to get you started and keep you going.