Responsable Affaires réglementaires / Dispositif Médical

About this role

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. 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.