BrabantWallon – contracting
#MedicalDevice #Diagnostic #InVitro
Our partner is looking for a In-Vitro Diagnostic(IVD) Devices Quality Lead to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
The role works closely with internal and external business partners in driving quality into the IVD pre- and post-market activities, covering rare diseases, including gene therapy. It provides QA input to cross functional teams dealing with complex and/or important projects and issues through clinical and CMC phases.
- Train and influence internal stakeholders to IVD requirements/processes in connection to Pharma and GCP processes.
- Participate to IVD’s requirements definition, partners selection and monitoring.
- Oversee Design & Development activities to IVD partners.
- Interact as IVD’s QA point of contact with Regulatory CMC & Devices, Pharmaceutical teams, Research Quality, Clinical, Biomarker team in early phase development and commercial organization.
Who are you?
- You hold a masters’s degree in in a relevant discipline (Pharmaceutical, Biomedical-Engineering, Biotechnology, Biology, or related fields) or you have similar work experience
- You have at least 2 to 5 years of experience in Quality OR Clinicals studies of IVD’s or Medical Devices.
- You have a good knowledge of regulations, standards and guidance applicable to IVD products including (but not limited):
- ISO norms
- CLSI Guidelines
- You have experience with IVD regulations of RUO products, Lab Developed Tests, Clinical Trial Assay, Commercial IVD MD and processes for design control, risk management, conformity assessments, vigilance and post-market surveillance.
- You are fluent in English (both written & spoken).
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Aurélie Montes Suarez: [email protected] or +32472/44.83.18