Senior QARA Medical Device

<p>At Excelya, we are committed to fostering an environment defined by <strong>Audacity, Care, and Energy</strong>. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies. </p><p>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. </p><p>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.</p><p>Main responsibilities : </p><p></p><ul><li>Maintain and continuously improve the Quality Management System (ISO 13485 compliant)</li><li>Ensure regulatory compliance throughout product design and development in close collaboration with project teams.</li><li>Oversee Design Control, risk management, and technical documentation activities.</li><li>Define and implement the Quality and Regulatory Affairs strategy.</li><li>Plan and manage internal and external audits.</li><li>Develop, review, and optimize quality processes, procedures, and documentation.</li><li>Manage product technical files and act as key contact for regulatory authorities and external stakeholders.</li><li>Monitor regulatory changes (EU &amp; US) and support internal capabilities, including FDA requirements.</li></ul>