Clinical Evaluation Manager
vor 1 Woche
This role involves the preparation of clinical evidence packages to meet registration requirements predominantly for CE-marking, Health Canada and FDA, but also to address additional markets. The role involves evaluating the safety and performance of Nobel Biocare products according to applicable regulatory requirements, in addition to conducting literature searches to retrieve valuable data regarding their real-world performance, planning and evaluating post-market clinical follow-up activities, and the creation of SSCPs. The role plays a significant part in both the development of new products and in the management of lifecycle projects.
**Job Requirements**:
- Higher degree in a relevant scientific discipline or equivalent
- Understanding of global clinical processes and clinical investigation design in the course of product development for medical devices (ISO 14155)
- Strong interpersonal skills and ability to work both independently and within a team environment
- Strong scientific understanding, ability to face complex problems and identify adequate solutions with a cross functional impact
- Fluent in written and spoken English, any other language is an asset
- Strong background in Clinical Evaluation processes, PMCF, and SSCP preparation, in a medical device industry setting,
- Solid working knowledge of Medical Device Regulation, MEDDEV 2.7.1 rev. 4, and applicable MDCGs.
**Operating Company**:
Nobel Biocare
**About Envista**:
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.
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Clinical Research Associate
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Clinical Education Manager
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Clinical Research Associate
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Biological Product Safety Manager
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Kloten, Zürich, Schweiz Swiss International Air Lines AG VollzeitTasksWe're set to roll out a comprehensive learning & development initiative within SWISS. Your role? To ignite awareness, foster unified understanding, set clear expectations, guide and equip our leaders and employees by promoting existing as well as creating new measures.Design and implement specific work packages within our Development & Learning...
