Senior QARA Medical Device

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.