Quality Assurance & Regulatory Affairs Specialist (Med Device) – France

Excelya>All job opportunites>Full-time, Permanent Contract>Quality Assurance & Regulatory Affairs Specialist (Med Device) – France

Job description

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.

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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory Affairs Medical device. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

  • Manage product withdrawal processes and related documentation.
  • Upload relevant documents to regulatory portals.
  • Ensure compliance of regulatory databases.
  • Coordinate between local affiliates, headquarters, and manufacturers.
  • Support due diligence for Digital Health projects, reviewing regulatory strategies and quality systems.
  • Review and implement quality and vigilance contracts with partners/start-ups.
  • Monitor regulatory compliance for product development and pre-launch activities.
  • Provide training and support to start-ups/partners and legal manufacturers.
  • Validate communication and promotional materials for Digital Health products.
  • Coordinate post-marketing surveillance platforms and ensure transparency and compliance.

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

  • Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—talent matters most to us!)
  • Skills: CDx (Companion Diagnostics), IVD (In Vitro Diagnostics), Reg Submissions IVD/PSA/IDE knowledge 
  • Education: Master’s degree 
  • Languages: French and good skills in English 

 

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