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
Clinical Evaluation Specialist / Manager
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 lifecycle maintenance purposes. The Clinical Evaluation Manager/Specialist ensures timely execution of clinical evaluation activities to support project needs and compliance.
Your main responsibilities are:
Cross-functional collaboration on new product development and lifecycle projects, providing subject matter expertise & clinical evaluation deliverables
Review of technical documents & risk assessments, marketing claims, and post-market surveillance data
Development and review of clinical evaluation plans, clinical evaluation reports, PMCF plans, PMCF evaluation reports, and Summaries of Safety and Clinical Performance (SSCPs)
Alignment with Clinical Operations on PMCF needs
Identification and screening of business and product-relevant scientific literature and development of clinical position statement
Analysis/interpretation of clinical study results and compilation of literature search reports for regulatory submissions
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 Bachelor’s degree or equivalent in a relevant scientific discipline, engineering, or medical technology
Several years of experience as a clinical evaluator for medical devices
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)