Role Description
Create a positive difference to the health of children worldwide, and become part of an experienced team developing software which ensures precise and standardised readings within radiology.
This is an opportunity to expand your knowledge and gain full insight and overview of what it takes to bring medical devices to the market from planning to release. You will get to exercise your skills in QA/RA and will learn along the way.
On the RA side, we are already active in more than three regions, and you will be joining us in both identifying and adapting to new regulatory requirements as we grow. On the QA side, we need someone who embraces all aspects of risk management and the collaboration between different stakeholders (i.e cybersecurity, development and clinical).
Quality assurance is closely integrated with all other areas in the company, and you will therefore work closely with other colleagues. We aim at having a simple QMS to which everyone in the company contributes, and which requires minimal maintenance. Your work will focus not only on maintaining the existing system, but also on implementing procedures and systems which improve workflows and safety.
What we do
Visiana has developed the software BoneXpert which through artificial intelligence automatically interprets a digital X-ray of a child's hand. BoneXpert determines how old the child is according to its biological clock, and this is used e.g. in relation to growth hormone treatment, and to predict how tall the child will become as an adult. This interpretation was traditionally performed by a radiologist, but our software can replace the radiologist's work. The software is already CE-marked and is available in multiple regions. It is currently undergoing upgrades in terms of documentation regarding the new MDR requirements.
Your work will include a subset of following areas
- All aspects of risk management in collaboration with colleagues from all departments
- Maintaining and improving the effectiveness of the QMS.
- Implementing and simplifying existing procedures and systems.
- Product realization (without responsibility for clinical aspects, usability, and PMS).
- Handling documentation packages for FDA / MDR and different authorities.
- Communication with representatives from different countries.
- Continual improvement and development of the quality management system.
- Proactively engaging with the organization to ensure effective compliance to set procedures and regulations.
- Overseeing internal and external audits.
- Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements.
- Ensure that regulated processes and systems in Visiana are always inspection-ready.
Your qualifications (not necessarily all)
- A relevant background in QA/RA, as a health care professional, or in software development.
- Experience working with risk management
- Certification for passing courses in ISO13485:2016, ISO 14971:2019, IEC 62304
- 3+ years of experience in the Medtech industry.
- Experience with medical device regulations within EU and US.
- Interest and willingness to work systematically and document work in our QMS.
- Interest in contact with authorities, customers, and external quality assurance experts.
- Interest in new technologies and streamlining processes where it makes sense.
- You can work independently and engage in constructive interaction with your new colleagues.
- You have excellent English skills, additional languages are an advantage.
- You have good analytical and technical skills.
Benefits
- Competitive salary
- An environment where you’re expected and encouraged to influence the company’s direction.
- An environment where you’re given a large amount of freedom in planning and executing your work.
- Flexible work hours and location. We like to meet in the office most days, but you can expect flexibility.
- An office within DTU Science Park in Hørsholm, with an excellent lunch.
- Collaborate with ambitious and dedicated people.
- Possibilities to learn and grow within medtech, while working on a device that is already on the market.
- An opportunity to work with AI software that has strong brand-recognition amongst potential customers.
For more information or questions please contact us at vilic@visiana.com
