What’s the challenge you would help us to solve and how?
MVision was born out of a deep desire to harness AI in winning the war on cancer. We exist to optimize radiotherapy treatment that 60% of all cancer patients undergo.
More and more cancer clinics around the world are putting their trust in our solution. With strong demand and growth, it is crucial for us to make sure the regulatory affairs and quality management remain on point also in the future. And we need your help with that!
What would you work with?
This is the perfect opportunity for a specialist with ca. 2 years of experience in regulatory tasks or quality management who now wants to take a step to a more senior role. Your tasks would include:
- Medical device software regulatory activities for MDR and FDA compliance, and MDD up keeping
- Regulatory assessment preparations and reviews
- Communicating with partners as well as updating technical documentation of medical devices.
- Maintaining quality management systems
Our QMS already has a 13485-certificate and now the system needs to be maintained and evolved according to the standard and good practices. You would work together with sales, development, and customer success teams to make processes smooth and compatible with regulations and standards. All processes should follow applicable standards and regulations (ISO 13485, IEC 62304, FDA, MDR etc.).
We are a small, passionate team in a very open and flexible working environment. You’d be welcomed with open arms to also influence in the ways of working. Your background and interests would, of course, also affect the details of the role and there is help available.
Skills we are looking for
- 2-3 years of experience in regulatory affairs and/or quality management
- Experience in complex project management
- Willingness to occasionally travel for work
- Fluent skills in English (no Finnish required)
- Sincere resonance to our cause
It also is seen as an advantage if you have previously worked with medical devices.
Apply by sending your CV and a potential cover letter to email@example.com ASAP.
Position: Permanent, full time
Start: As soon as possible
Location: HQ in Helsinki but you choose where you work
If you have any questions, feel free to reach out to firstname.lastname@example.org