Responsable QARA Dispositifs Médicaux

Excelya; Dijon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya in Dijon, France, seeks a senior Regulatory Affairs professional to lead regulatory strategies across devices and life sciences. You will ensure compliance during design and development, steer quality processes, and collaborate with cross-functional teams to drive global submissions.

The role emphasizes experience with Class II medical devices, ISO13485, and lifecycle management, offering a path to shape regulatory excellence within a dynamic CRO environment.

Qualifications

• Master's degree in life sciences, pharmacy, chemistry, or a related field.
• Proven experience in Regulatory Affairs within pharma/biotech/medical devices, including global submissions and lifecycle management.
• At least 10 years of QARA experience within the medical device field.
• Significant experience with Class II medical devices.

Responsabilités

• Maintain and improve the Quality Management System (ISO 13485 compliant).
• Ensure regulatory compliance throughout product design and development 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.
• Monitor EU & US regulatory changes and support FDA requirements.

Connaissances

Regulatory knowledge

Quality systems

Stakeholder management

Communication skills

Organizational skills

Formation

Master's degree in life sciences

Description du poste

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.

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)

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.