The role
You will play a crucial role in our MDR project, focusing on achieving certification for MDR components and integrating MDR compliance throughout the organisation. As MDR develops in Columna CIS, your role may expand to include responsibility for developing, implementing and optimising processes related to software medical devices across the organisation. We may also expect you to take on the role of PRRC (Person Responsible for Regulatory Compliance) for software medical devices.
Your job will consist of the following tasks:
- Establish and maintain technical files for MDR component(s)
- Collaborate with customers/experts regarding clinical evaluation and usability studies
- Work with risks in relation to MDR
- Collaborate with notified body
- Advise project teams on MDR activities, including classifications and activities related to technical files
- Help set the direction for MDR certification
- Plan and execute post market surveillance
- Establish intended use for potential software medical devices
Your profile
We expect you to be a seasoned MDR Specialist with min. 5 years of experience from a similar position, and you have extensive experience with the MDR area and medical device compliance within the software area.
In addition, you have:
- extensive experience with software medical device classifications and the establishment of technical files and a willingness to be practically executing
- experience with clinical evaluation, usability and risk management in relation to MDR
- experience with regulatory approval of software as a medical device
- extensive experience with ISO 13485 and related standards, as well as with obtaining certifications
- experience with software development and the MDR certification of software solutions
It is crucial for the position that you are fluent in Danish and English, both written and spoken. Non-Danish speakers will not be considered for the position.
Stakeholder management – both internally and externally – is important for success in this position. Since most internal stakeholders are based at the company’s Aarhus HQ, we expect you to work from here, or to be willing to travel to Aarhus several times a week.
As a person you:
- have an independent work style with the ability to drive initiatives forward
- take a proactive approach to identifying and solving regulatory challenges
- have a strong analytical mindset for complex regulatory requirements
- have good communication skills, and you are excellent at stakeholder management
- are detail-oriented and take a systematic approach to documentation
- are a collaborative team player who can work across multiple departments
Welcome to Systematic Aarhus
At our Aarhus office, you can look forward to joining our Employees Club, which offers nearly 100 social/professional events a year. Here, you can take advantage of a range of on-site perks from physiotherapist-led massages and an in-house hairdresser to sports clubs, games tables and even our own padel court. Our canteen is a standout feature, serving a daily selection of delicious and healthy dishes. Beyond the office, you will also enjoy benefits like free ARoS +1 access and various shopping discounts.
Never stop developing
Systematic is uniquely people-centric, truly international and proudly rooted in Denmark with more than 1,100 employees. Together, we write intelligent and innovative code to drive progress and improve lives. We develop IT solutions that make a real difference where it matters most, and this is why we never stop developing. Here, there is room to be professional and personal. Systematic is not just a place to work but a place to belong.