Regulatory Compliance Expert online predictionmodel
In recent years, we have developed and tested in clinical practice the online SOURCE (Stimulating evidence-based, personalized and tailored information provision to improve decision making after esophageal cancer diagnosis) 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.
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.
- You will be employed by Amsterdam UMC Research BV.
- A contract for 14 months.
- Salary scale 10: € 3.598 to € 5.669 gross based on full-time employment (depending on education and experience) and a year-end bonus of 8.3%. Calculate your net salary here.
- Holiday hours: 190.4 per year for fulltime and a possibility to save additional hours.
- Pension accrual with BeFrank, a modern, comprehensible and fairly priced pension.
- 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.
Watch this video with more information about joining Amsterdam UMC Research BV.
You will work within the SOURCE project at the Department of Medical Oncology at Amsterdam UMC. Here both clinical care and research is performed, ranging from basic research to clinical trials and projects with large real-world datasets, such as SOURCE. The department is characterized by an open culture, in which colleagues support each other.
The SOURCE project is supervised by Prof. Dr. Hanneke van Laarhoven (medical oncologist), Dr. Rob Verhoeven (epidemiologist) and Ruben Boyd (business developer) and was funded by KWF.
During the publication period, applications will be considered on a continuous basis. When the vacancy is filled, it will be closed early.
Do you have any further questions? For substantive information about this vacancy, please contact Rob Verhoeven, Associate Professor, via r.h.verhoeven@amsterdamumc.nl.
For more information about the application process, please contact Tanja Hart, recruitment consultant, via 06 21603178 or at t.hart@amsterdamumc.nl.
A reference check, screening and hiring test may be part of the procedure. Read here whether that applies to you. If you join us, we ask you for a VOG (Certificate of Good Conduct).
Internal candidates will be given priority over external candidates in case of equal suitability.
Acquisition in response to this vacancy will not be considered.