About the role
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 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+ experience of working in a 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.
- Project management skills.
- 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 you motivation letter together with you full CV and motivation letter to info@amberimplants.com
For more information you can always contact us.
We directly source all candidates – any unsolicited profiles received from recruitment agencies will be
treated as direct applications.