Medical Writer
il y a 3 jours
**About the Job**
Join Excelya, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
We are currently looking for a Medical Writer focused on Clinical Evaluation for Medical Devices to join our growing team. This position will provide you with the opportunity to work on exciting projects that contribute to the advancement of medical technologies.
Reporting to the Head of Clinical Evaluation & Medical Writing, your primary mission will be to develop and maintain clinical evaluation documentation for implantable medical devices (Class IIb and III).
**Main Responsibilities**:
- Perform systematic scientific literature searches, selection, and critical analysis
- Build comprehensive state-of-the-art summaries on pathologies, standard of care, and available therapies
- Contribute to CE marking submissions and renewals
- Write and/or update Clinical Evaluation Plans and Reports in line with MEDDEV 2.7/1 rev.4 and EU MDR 2017/745
- Support Post-Market Clinical Follow-up activities (PMCF Plans & Reports)
- Work closely with Regulatory Affairs, R&D and Engineering teams (risk analyses, responses to Notified Bodies, clinical justifications, etc.)
- Support dissemination of scientific knowledge and product-specific data
**Requirements**:
**About You**
We seek motivated and skilled individuals who are ready to contribute to our mission with a strong focus on quality and accuracy:
- **Education**: University degree in life sciences, biomedical engineering, or a related field.
- **Experience**: A minimum of 2 years of experience in writing Clinical Evaluation Reports under MEDDEV or EU MDR
- **Skills**: Strong understanding of clinical research processes and regulatory requirements for medical devices.
- Excellent writing and editing skills with attention to detail.
- Proficient in conducting literature searches and analyses.
- **Languages**: Proficient in English (written and spoken)
**Benefits**
**Why Join Us?**
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's **leading mid-size CRO**with the **best employee experience**. Our **one-stop provider service model**—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
**Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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