Responsable Affaires réglementaires / Dispositif Médical

<p>At Excelya, we are committed to fostering an environment defined by&nbsp;<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>Develop and implement regulatory strategies to support product development, registration, and market access activities</li><li>Prepare, maintain, and update Technical Documentation in accordance with MDR 2017/745 requirements.</li><li>Coordinate CE Marking activities</li><li>Assess the regulatory impact of product changes throughout the product lifecycle.</li><li>Ensure compliance with applicable standards and regulations, including MDR 2017/745, ISO 13485, and ISO 14971.</li><li>Support Post-Market Surveillance (PMS), Vigilance, and Post-Market Clinical Follow-up (PMCF) activities.</li><li>Participate in internal and external audits, inspections, and regulatory assessments.</li><li>Interface with Competent Authorities, and external regulatory partners.</li><li>Monitor and interpret regulatory developments and communicate potential impacts to stakeholders.</li><li>Collaborate closely with Quality Assurance, R&amp;D, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.</li><li>Provide regulatory guidance and training to cross-functional teams.</li></ul><p><strong>Requirements</strong></p><p><strong>About you</strong></p><p><strong>Education:</strong> Master’s degree in life sciences, pharmacy, chemistry, or a related field</p><p><strong>Experience:</strong> 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 &amp; Regulatory Affairs) within the medical device field. Significant experience with Class II medical devices. </p><p><strong>Skills:</strong> 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. </p><p> <strong>Languages:</strong> Fluent in English and French (written and spoken) </p><p><strong>Benefits</strong></p><p><strong>Why&nbsp;Join&nbsp;Us?&nbsp;</strong></p><p>At&nbsp;Excelya,&nbsp;we&nbsp;combine&nbsp;passion&nbsp;for&nbsp;science&nbsp;with&nbsp;enthusiasm&nbsp;for&nbsp;teamwork&nbsp;to&nbsp;redefine&nbsp;excellence&nbsp;in&nbsp;healthcare.</p><p>Here's&nbsp;what&nbsp;makes&nbsp;us&nbsp;unique—</p><p>We&nbsp;are&nbsp;a&nbsp;young,&nbsp;ambitious&nbsp;health&nbsp;company&nbsp;representing&nbsp;900&nbsp;Excelyates,&nbsp;driven&nbsp;to&nbsp;become&nbsp;Europe's&nbsp;<strong>leading&nbsp;mid-size&nbsp;CRO&nbsp;</strong>with&nbsp;the&nbsp;<strong>best&nbsp;employee&nbsp;experience</strong>.&nbsp;Our&nbsp;<strong>one-stop&nbsp;provider&nbsp;service&nbsp;model&nbsp;</strong>—&nbsp;offering&nbsp;full-service,&nbsp;functional&nbsp;service&nbsp;provider,&nbsp;and&nbsp;consulting&nbsp;—&nbsp;enables&nbsp;you&nbsp;to&nbsp;evolve&nbsp;through&nbsp;diverse&nbsp;projects.&nbsp;Working&nbsp;alongside&nbsp;preeminent&nbsp;experts,&nbsp;you&nbsp;will&nbsp;help&nbsp;improve&nbsp;scientific,&nbsp;operational,&nbsp;and&nbsp;human&nbsp;knowledge&nbsp;to&nbsp;enhance&nbsp;the&nbsp;patient's&nbsp;journey.</p><p><strong>Excelling&nbsp;with&nbsp;care</strong>&nbsp;means&nbsp;benefiting&nbsp;from&nbsp;an&nbsp;environment&nbsp;that&nbsp;values&nbsp;your&nbsp;natural&nbsp;talents,&nbsp;pushes&nbsp;boundaries&nbsp;with&nbsp;audacity,and&nbsp;nurtures&nbsp;your&nbsp;potential,&nbsp;allowing&nbsp;you&nbsp;to&nbsp;contribute&nbsp;fully&nbsp;to&nbsp;our&nbsp;shared&nbsp;mission.</p><p>Find <a href="https://www.arbeitnow.fr">Jobs in France</a> on Arbeitnow</a>