What you will do
As Clinical Scientist and Medical Writer you will be part of the Clinical and Regulatory team, collaborating closely with other teams for the development of the Go-2 system, an active implantable medical device for spinal cord stimulation.
The main responsibilities of this position include:
- Generate relevant medical device clinical data to support the different departments such as Product Development, Market Access, Clinical and Regulatory. This includes the use of all available means such as literature review, pre-clinical and clinical studies
- Actively contribute to the writing of important clinical-regulatory documents for medical device, such as Clinical Investigation Plans and Reports, Clinical Evaluation Report, Risk Management and IFUs
- Conduct research and analyze the available clinical data from various medical device studies as input for internal reports and external publications (clinical publications, Usability and Quality of Life data for Market access and Reimbursement purposes)
- Ensure and bring clinical savvy to the engineering teams. Provide input for Product Design aspects and translate technical device requirements for evaluation into clinical data
What we are looking for
- You hold a master’s degree in Engineering, Biomedical Engineering, Medical or Paramedical sciences;
- You have at least 5 years’ experience in the Medical Device industry within a business context or Clinical Research Organization, preferably active implantable medical devices;
- You have experience with clinical literature review and / or clinical study data management;
- You possess strong medical-device writing skills and have a thorough understanding of regulatory processes in MedTech: Medical Device Directive and Medical Device Regulation;
- You have experience with documentary requirements for Medical Devices, in particular essential documents such CIP, CER and Risk Management;
- You are an energetic, hands-on individual and enjoy working in an international, cross-functional environment within a young and growing company;
- You communicate fluently in English as this is our company language; proficiency in French and/or Dutch language is highly appreciated;
- You are willing to travel regularly between clinical sites and GTX offices within Europe (mainly Netherlands and Switzerland).