Aktuelle Jobs im Zusammenhang mit Internship in Clinical Affairs - Zurich - Lumendo AG
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Clinical Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Hays Vollzeit**My duties** - Directing and overseeing short-team and long-term planning of clinical data acquisition for regulatory submission initiatives - Leading pre-market clinical investigations and post-market clinical follow-up of the clients’ medical devices, with the goal to reach earliest possible approval of regulatory submissions - Designing clinical data...
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Clinical Evaluation Manager
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Clinical Evaluation Manager
Vor 2 Tagen
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Clinical Evaluation Manager
vor 1 Woche
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Clinical Evaluation Expert
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Clinical Director
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Quality and Regulatory Affairs Manager
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Regional Director Medical Affairs
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Eucan Regulatory Manager
vor 1 Woche
Zurich, Schweiz Takeda Pharmaceutical VollzeitAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Regulatory Manager - Clinical Trials** in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** Under supervision from a senior team member and/or in collaboration with EUCAN Regulatory Lead: -...
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Regulatory Affairs Manager
Vor 4 Tagen
Zurich, Schweiz Akina VollzeitAkina is a leading developer of medical software to empower patients during independent physiotherapy at home. With an AI-driven motion coach and unique entertainment integration, Akina addresses the lack of clinical feedback and motivation that causes 4 out of 5 patients to fail during self-care at home today. As a regulatory affairs manager at Akina, you...
Internship in Clinical Affairs
vor 2 Wochen
Lumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth longer.
Job description
The technology of the endodontic cleaning device and the light-activated filling material have been developed by Lumendo over the last 3 years. We are going to launch our first clinical trials with the products this year.
You will support the Clinical Affairs Manager in designing study protocols, performing systematic literature searches, preparing clinical evaluation reports (CERs) and development of Trial Master Files (TMFs). You will be involved in all stages of clinical trials process starting from clinical trial design, essential documents preparation and submission to ethical & regulatory committees, preparation of TMF through the launch of the trial, management of necessary documentation and data collection during the trial until the closure of the trial. Through this, you will gain first. Hand experience in clinical affair within medical devices.
You will work together with a team of 5 scientists and engineers who have developed the prototypes from the beginning. You will further interact with experienced clinicians and advisors relevant to the development of a medical device.
Tasks
- Support the team with medical/ scientific expertise to develop study protocols and related documents
- Perform systematic literature searches, interpret and analyze publications, summarize findings in reports
- Assist in writing clinical evaluation reports
- Develop standard operation procedures related to clinical studies
- Write documentation related to TMF
- Participate in meetings with investigators, write meeting minutes
**Requirements**:
- Master degree in medicine/ dentistry or life sciences (biomedicine, Biotechnology, Biology, or similar)
- Interest in medical devices for dentistry
- Highly motivated and responsible; Independent and well-organized working style.
- Ability to work in a team
- Good analytical and organizational skills
- Knowledge of the regulations applicable to clinical trials (ISO 14155:2020, EU MDR, ICH-GCP) is a plus
- Proficiency in English (written and spoken)
**Benefits**:
- A work that matters and can help improve people’s life.
- A startup environment, giving you high responsibility and lots of freedom.
- A young, entrepreneurial, international and motivated team of 8 people.
