# Senior QARA Medical Device

> Excelya · Lyon, France · Full-time · Posted 2026-06-08

**Workplace:** on_site

**Department:** Regulatory Affairs - Resourcing

## Description

At Excelya, we are committed to fostering an environment defined by **Audacity, Care, and Energy**. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity for a regulatory affairs Manager to lead strategic regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance.

You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of healthcare products.

Main responsibilities :

-   Maintain and continuously improve the Quality Management System (ISO 13485 compliant)
-   Ensure regulatory compliance throughout product design and development in close collaboration with project teams.
-   Oversee Design Control, risk management, and technical documentation activities.
-   Define and implement the Quality and Regulatory Affairs strategy.
-   Plan and manage internal and external audits.
-   Develop, review, and optimize quality processes, procedures, and documentation.
-   Manage product technical files and act as key contact for regulatory authorities and external stakeholders.
-   Monitor regulatory changes (EU & US) and support internal capabilities, including FDA requirements.

## Requirements

**About you**

**Education:** Master’s degree in life sciences, pharmacy, chemistry, or a related field

**Experience:** Proven experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, including involvement in global submissions and lifecycle management activities, experience in cross-functional collaboration or project coordination is a plus. At least 10 years of experience in QARA (Quality Assurance & Regulatory Affairs) within the medical device field. Significant experience with Class II medical devices.

**Skills:** Strong knowledge of regulatory requirements and submission processes, as well as post-approval activities, good understanding of quality systems and product development; excellent communication, stakeholder management, and organizational skills.

**Languages:** Fluent in English and French (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.

## Apply

[Apply at Excelya](https://apply.workable.com/excelya/j/7DB210146E/apply)

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