Amber Implants is seeking a Clinical Scientist with expertise in clinical data analysis, medical device technology, and implementing healthcare innovations. The ideal candidate will possess a strong scientific background and understanding of regulatory requirements for conducting clinical studies. In this role, you will play a key part in the development, verification, and validation of medical devices in both European and US markets. Collaborating closely with the R&D team, regulatory advisors, CRO, and clinicians, you will report to the management. Additionally, you will receive internal coaching to facilitate a rapid learning curve for company activities.
What you will do
- Prepare and document clinical evaluation documents.
- Collaborate with medical professionals to develop study protocols for clinical trials and to analyze data.
- Prepare and submit regulatory documents for the FDA or European authorities related to clinical trials according to the company strategy.
- Assist in any way necessary with the execution of the clinical trials.
- Control/assist on data collection, management and validation processes, using the data management systems.
- Occasionally attend surgeries in different countries.
- Perform clinical Data Analysis and statistical analysis of data.
- Collaborate with internal R&D, engineering, and marketing teams to integrate clinical insights into product development, ensuring that spine devices meet both clinical and market needs.
- Perform relevant preclinical V&V activities.
- Attend cadaveric functionality testing for training or validation purposes.
- Writing scientific articles and grants.
You have
- MD, PhD or Master degree in Biomedical Engineering, Clinical Research, or similar.
- 2+ years of experience working in the medical device industry and preferably clinical study experience.
- Knowledge of and experience in working with clinical data that are relevant to database management and analysis.
- Experience working under QMS for medical devices.
- Self-driven, persistent and results-oriented.
- Strong sense of responsibility, respect timelines and schedules.
- Fluency in English. Dutch and German would be nice to have.
About the company
Amber Implants is a fast-growing clinical-stage medical device start-up operating in the orthopedics and trauma field. We have created a novel spinal implant (VCFix Spinal System) for treating traumatic vertebral fractures in a minimally invasive approach. We have completed all preclinical testing of this product and started in-human clinical trials. Amber Implants has a flat organizational structure composed of a young, ambitious, and rapidly expanding team, located in WTC, the Hague, with a modern atmosphere and an informal culture. We are a company that recognizes your efforts, listens to your suggestions, gives you feedback to improve, and congratulates you on your achievements, making it a pleasant work environment. The vacancy is for a full-time position (36-40 hours per week). The employees are required to work from the office for this position.
To apply, please send your motivation letter together with your full CV to info@amberimplants.com.
We directly source all candidates – any unsolicited profiles received from recruitment agencies will be treated as direct applications.
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