Offre d'emploi : Product Development Manager IVD/CE Marking - FR/EN
Based in Gembloux at Créalys Science Park, Volition (https://volitionrx.com) is a multinational life-sciences company developing simple and easy tests for the accurate diagnosis of many forms of cancer. The tests are founded on the science of Nucleosomics®, detecting the presence of possible disease.
As cancer-screening programmes become more widespread, Volition products focus on aiding the diagnosis of an array of cancers quickly, easily and accurately. Early diagnosis can not only extend patients’ lives, but also improve their quality of life.
Volition has also just developed a reagent that determines the level of danger of Covid-19 to people tested with a blood test.
Volition’s research and development activities are currently centred in Belgium (approximately 32 staff), with additional offices in the United Kingdom, United States and Asia, while the company focuses on commercialising its diagnostic products primarily in Europe, then in the US and ultimately worldwide.
Volition has just invested in a second building in Créalys Park, to set up its production activities. Its products will be distributed globally.
In the context of its expansion, Volition requires the services of a:
Product Development Manager IVD/CE Marking - FR/EN
Within this new role, in collaboration with the Quality and Production Directors:
- You will plan and supervise projects to develop new products with a view to their market launch and you will ensure that the corresponding technical documentation is implemented and compliant, in collaboration with the different departments concerned,
- You will take part in the decisions relating to the choice of whether to develop and launch products in each country,
- You will hold internal meetings to prepare and monitor product development projects and give regular reports on project progress to Management,
- You will adapt existing products to the applicable regulatory requirements (IVDR, FDA, etc.) in the different countries targeted.
- You will carry out an active regulatory and legislative watch in collaboration with the QA/RA departments,
- You will provide regulatory support in the implementation and monitoring of clinical studies in collaboration with R&D,
- You will provide your support in the post-marketing follow-up of different products.
- You are educated to university level in a scientific discipline (biology, chemistry, etc.).
- You have had a substantial first experience (minimum 2-3 years) in developing products in the in vitro diagnostics (IVD) sector with a view to their market launch.
- You have knowledge of the applicable regulatory requirements.
- You are familiar with the development of immunoassays.
- You are an expert in project management.
- FDA/MDSAP practice is an asset.
- You speak fluent French and English.
- You are recognised for your excellent skills in writing and following quality and regulatory procedures.
- You are open to frequent travel within Europe.
- An attractive work environment in a flourishing (scientific) community in Wallonia.
- A Belgian company with real potential for international development.
- The prospect of adding you value within this role creation.
- A position with potential to grow together with the company.
- A friendly and dynamic work ambience.
- A new and easily-accessible work environment.
- An open-ended contract and attractive salary package.
Please submit your application online via the following link: http://www.habeas.be/job/
Ref. 545-007 (2021)
Your application will be processed quickly and in confidence. habeas is managing this assignment exclusively.