As Manager Clinical Research Endodontics, you'll work closely with the procedure teams (Strategic Marketing, Product Management and Research & Development) to support New Product Development and product maintenance activities. You'll also provide clinical and scientific insights and support regarding Clinical Research and Affairs.
Key Responsibilities
- Contributes to clinical design input, Product Requirement activities, Validation and Verification planning and execution
- Approves Product Change Orders as the clinical representative at the site
- Provides clinical input to Quality Assurance regarding product complaints and Health Hazard Evaluations when necessary
- Organizes and executes Internal and External /Professional Product Evaluations
- Plans and implements User Evaluations
- Actively engages with the Procedure team to develop Voice of Customer insights
- Provides clinical support for the review and approval of Instructions for Use
- Contributes clinical Input for the planning of clinical studies, in-vitro studies, Investigator Initiated Studies, and PMCF
- Supports Clinical/Regulatory Compliance with clinical expertise
- Engages with the Procedure team to provide with Scientific and Clinical Support such as Scientific Clinical Communication, Scientific Manuals, Literature Reviews, and White Papers.
- Assists with planning and delivery of product launch support materials such as, digital images and/or Video content for clinical compliance
- Support in the creation and review of technical files
- Support in the review of documentation (labelling)
Requirements and Qualifications
- MS degree or equivalent in dentistry or other related science; PhD degree or Certified Registered Dentist would be a plus
- 3+ years' related clinical experience, also covering Endodontic treatments
- Experience in Medical Device Industry and product development would be a plus
- Very good knowledge of European Regulatory rules (MDR) and US (21 CRF) concerning medical devices, FDA
- Experience in Medical Writing
- Very good knowledge of MS Office + ERP (i.e. MS Project
- Knowledge of clinical dentistry, especially the domain of Endodontics
- Excellent communication skills in English (C1/C2); French (B2) would be a strong plus
- Strong interpersonal skills with the ability to build great relationships with multiple stakeholders
- Team spirit
- Proactive, cooperative attitude
- High analytical skills
- Strong service- and customer-orientation
- Very good organizational and planning skills