About the role
Amber Implants is seeking a Clinical Research Specialist/Scientist with a strong background in clinical research, medical devices, and experience in hospital-based settings to join our dynamic clinical research team. The ideal candidate brings both scientific and operational expertise, a solid grasp of regulatory requirements, and comfort working in clinical environments, including direct support during surgical procedures.
In this role, you will contribute to the successful execution of clinical investigations that support the development and commercialization of innovative spine devices across European and US markets. You will collaborate with internal and external stakeholders, including R&D, RA/QA, contract research organizations (CROs), and clinical partners.
To support your professional growth, you will receive hands-on coaching and mentorship tailored to our internal processes and clinical strategy.
What you will do
- Provide on-site clinical support to surgeons during device implantation procedures in hospitals across multiple countries.
- Draft and contribute to the development of key clinical documents, including study protocols, informed consent forms (ICFs), and investigator brochures (IBs).
- Prepare clinical trial submissions to regulatory authorities, including the FDA and European Competent Authorities, in line with company objectives.
- Oversee study site activities to ensure timely patient enrolment, data collection, and protocol compliance.
- Conduct data review, cleaning, and validation to ensure integrity and reliability of clinical data.
- Assist with clinical data analysis, including statistical interpretation to support reporting and decision-making.
- Collaborate with internal R&D, design-, and marketing teams to translate clinical feedback into product development strategies and ensure clinical relevance.
You have
- A Master’s or Bachelor’s degree in Biomedical Engineering, Biomedical Sciences, Clinical Research, Nursing, or a related field.
- At least 1 year of experience in the clinical research field, preferably with medical devices
- Experience in the medical device industry.
- Knowledge of the spine or orthopedic field is a strong plus.
- Familiarity with clinical data management and statistical analysis processes.
- Strong project coordination skills with the ability to manage timelines and priorities across multiple stakeholders.
- Experience working within a Quality Management System (QMS) in accordance with ISO 14155 and/or FDA 21 CFR Part 812 is a plus.
- Proactive, results-oriented, and capable of working independently.
- High level of accountability and commitment to quality and compliance.
- Excellent written and verbal communication skills in English; proficiency in Dutch and/or German or French is a plus.
- Ability to work from the company office is a requirement; limited remote work is possible.
- Ability and willingness to travel internationally (inside or outside EU) as required.
- The vacancy is for a full-time position (36-40 hours per week).
About the company
Amber Implants is a fast-growing, dynamic medical device start-up with a mission to bring innovative spinal implants to patients worldwide. Based in the Netherlands, we are proud of our internationally oriented team, combining diverse expertise and a collaborative spirit to drive meaningful clinical impact. Join us and be part of a passionate company where your contributions directly shape the future of patient care.
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.