"Regulatory Compliance Expert online predictionmodel"

In recent years, we have developed and tested in clinical practice the online SOURCE tool. This tool provides physicians and patients with personalized information about survival, complications and quality of life after treatment for esophageal or gastric cancer.

To bring the SOURCE tool to practice, CE marking and a business plan are the next steps. In this 14-month project, you will work with physicians, researchers and business developers to get the SOURCE tool ready for CE marking and develop a business plan.

You will work on a challenging project to achieve CE marking for an online tool that provides patients with esophageal or gastric cancer with personalized information about treatment choices (prediction model). In addition, you will develop a business plan for this SOURCE tool. You will work with physicians, researchers and business developers to prepare the tool for implementation.

Your tasks include:

• prepare documentation around the SOURCE tool and CE marking;
• write business plan for the SOURCE tool;
• consult with internal stakeholders;
• liaise with external stakeholders, such as companies involved in CE marking and commercialization.

In this regulatory compliance expert position, you will have ample opportunities to connect practice and innovation, contribute to implementation of personalized care, gain experience in medical technology, regulation and valorization, and access to a large interdisciplinary network of physicians and researchers.

Requirements: You have completed or will soon complete a relevant master's degree. In addition, you have: demonstrable experience in preparing medical devices for CE marking; experience in preparing business plans (preferred); good oral and written communication skills in English; a result-oriented, analytical, proactive and structured work attitude.

Conditions of employment: You will be employed by Amsterdam UMC Research BV. A contract for 14 months. Salary scale 9: € 3.765 to € 5.160 gross based on full-time employment (depending on education and experience) and a year-end bonus of 8.3%. Holiday hours: 190.4 per year for fulltime and a possibility to save additional hours. Pension accrual with BeFrank. For >7 km each way, 100% reimbursement for public transport travel costs and, for private transport, €0.18 per km up to a maximum of 40 km each way. Do you prefer walking or cycling? Take advantage of our good bike scheme. Moreover, you will receive a reimbursement of €0.18 per km. You will work within the SOURCE project at the Department of Medical Oncology at Amsterdam UMC.