Are you eager to develop your medical regulation expertise?

At Quantib we come to work every day to solve the radiologist’s hardest challenges and to make sure they can spend their time in the most valuable way. Medical images enclose secrets about diseases we wish to unravel just as much as physicians do. Our software helps radiologists and other medical specialists to accurately detect the clinically significant abnormalities within the human body. If you’re excited about moving healthcare forward using artificial intelligence, we’d love for you to join us.

Quantib isn’t the kind of place where you work on your own little project without connecting to your colleagues. We are a tight team offering each other unconditional support. With a scale-up size (27 people and counting) and an agile workstyle, we easily adapt our workplan to setbacks and windfalls.

Your goal

Your core goal is to get our medical software approved for clinical use. A crucial step in the product development process, as we are not allowed to sell the software without this stamp of approval. This will require close collaboration with your quality colleagues, but also with our R&D team and with marketing. On a day-to-day basis you will work on writing and checking technical documentation required for the certification processes.

Your responsibilities

• Write use-analysis reports in which you describe the main workflow of the end user.
• Participate in risk analysis of the medical device and documenting the outcome.
• Describe (with the help of our R&D engineers!) the algorithms integrated in the software products and the software design itself.
• Search literature and investigating existing products to demonstrate the safety and clinical value of our products.
• Write test scenarios that cover all of the product requirements.
• Write user guides and manage their translations.
• Compile technical files to obtain market access by for example 510(k) clearance and CE marking.
• Maintain device master records of the various products marketed by Quantib.
• Keep track of regulatory requirement changes. 

Your key competencies

• You have excellent analytical skills, you are precise in your work, applying your eye for detail comes naturally to you.
• You are concise and clear in your English writing, additionally, your spoken English is at a professional level.
• You have an affinity with medical science and are curious to learn more about the ways of working of radiologists.
• You love to work in diverse teams, but you are also happy to work independently on certain tasks.

Just a few other requirements…

• An MSc degree in (biomedical) engineering plus a demonstrable interest in and talent for technical writing.
  OR
• Any other higher education degree with demonstrable experience with and talent for technical ICT documentation.
• A Dutch or EU working permit.

… and what will we offer you?

• You will be working in a dynamic and highly qualified team of 27, a lively mix of R&D engineers, AI specialists, combined with marketing, quality staff and clinicians who walk in and out to support us with their medical know-how.
• You will enjoy a steep learning curve as you collaborate with international large and small enterprises in product development.
• Our quality team will train you in the necessary procedures and guidelines for production of medical devices and bring you to the next level of quality and regulatory expertise in particular in relation to using artificial intelligence in medical devices.
• Depending on your work experience you may start this position either as an Assistant or an Associate, there is room for training to bring your skills to a next professional level.
• Our main office is in Rotterdam, we ask you to spend most of your time there, but you will also have flexibility to work part-time or partly from home.
• Next to a salary in line with the job level, we will provide free team lunches 3 days a week and, of course, you will be invited to our regular QuantiBo drinks!

Are you enthusiastic about the position and interested in applying? Please upload your resume and motivation letter using the form below. Do you have any questions? You can reach us at call +31(0)108411749 and ask for Floor van Leeuwen, she knows the details!

Recruitment offers by commercial agencies are not appreciated.