Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single tooth to fully edentulous indications. We offer dental implant systems, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. We support customers throughout their professional and practice development. Nobel Biocare Headquarters is based in Zurich-Airport, Switzerland, and we have around 34 direct sales organizations worldwide. Nobel Biocare is a member of the Envista Cooperation.
To strengthen our Clinical Evaluation Team in Zurich-Kloten we are looking for a
This position within the Clinical Evaluation Team involves the clinical evaluation of a range of dental devices, both as a critical deliverable for market access in new product development projects, and for life-cycle maintenance purposes. The Clinical Evaluator ensures timely execution of clinical evaluation activities to support project needs and compliance.
Your main responsibilities are:
- Development and review of clinical evaluation plans, clinical evaluation reports, PMCF plans, PMCF evaluation reports, and Summaries of Safety and Clinical Performance (SSCPs)
- Cross-functional collaboration on new product development and life-cycle projects, providing subject matter expertise & clinical evaluation deliverables
- Review of technical documents & risk assessments, marketing claims and material, and post-market surveillance plans and reports
- Analysis/interpretation of clinical study results and compilation of literature search reports for regulatory submissions
- Identification and screening of business and product-relevant scientific literature and development of clinical position statements
- Alignment with Clinical Operations on PMCF needs
- Support other departments with clinical content and knowledge
Are you a service-oriented personality combined with strong analytical and problem-solving skills and the willingness to be part of an international, cross-functional team?
- A Master’s degree or equivalent in a relevant scientific discipline, engineering, or medical technology
- 3+ years’ experience as a clinical evaluator for medical devices, experience with software as a medical device (SaMD) desirable
- Proven writing skills, with the ability to convey data in a clear and concise way, with attention to detail
- Solid working knowledge of MEDDEV 2.7.1 rev. 4, MDR, and global clinical processes
- Strong interpersonal skills
- Fluency in written and spoken English (German is an advantage)