Responsable Affaires réglementaires / Dispositif Médical

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 :

• Develop and implement regulatory strategies to support product development, registration, and market access activities
• Prepare, maintain, and update Technical Documentation in accordance with MDR 2017/745 requirements.
• Coordinate CE Marking activities
• Assess the regulatory impact of product changes throughout the product lifecycle.
• Ensure compliance with applicable standards and regulations, including MDR 2017/745, ISO 13485, and ISO 14971.
• Support Post-Market Surveillance (PMS), Vigilance, and Post-Market Clinical Follow-up (PMCF) activities.
• Participate in internal and external audits, inspections, and regulatory assessments.
• Interface with Competent Authorities, and external regulatory partners.
• Monitor and interpret regulatory developments and communicate potential impacts to stakeholders.
• Collaborate closely with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.
• Provide regulatory guidance and training to cross-functional teams.