Clinical & Regulatory Affairs Associate in Medtech

vor 8 Stunden

Zurich, Schweiz Lumendo AG Vollzeit

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.

We have a team of 8 motivated scientists and engineers and recently
closed our seed financing round allowing us to bring the prototypes into
to support our clinical affairs team.

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 Chief Medical
Officer in designing study protocols, performing systematic literature
searches, preparing clinical evaluation reports (CERs) and regulatory
submission preparation. 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 affairs within medical devices.

You will work together with a team of
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 Lumendo’s medical devices.

Tasks
- Support the team with medical/ scientific expertise to develop clinical study protocols and related documents
- Perform systematic literature searches, interpret and analyze publications, summarize findings in reports
- Assist in writing clinical investigation plans, reports, clinical evaluation reports and other clinical study-related and regulatory documentation
- Manage all site-related communication for Lumendo’s clinical studies.
- Support with study-related documentation and submission responsibilities.
- Engage with study-related external vendors
- Develop standard operation procedures related to clinical studies
- Participate in meetings with investigators, and write meeting minutes

**Requirements**:

- Educational background in medicine/ dentistry or life sciences (biomedicine, Biotechnology, Biology, or similar)
- Interest in dental devices
- 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 lives.
- A startup environment, giving you high responsibility and lots of freedom.
- A young, entrepreneurial, international and motivated team of 10 people.

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