Regulatory Affairs Manager

--- base: meta-keywords: meta-viewport: width=device-width, title: Regulatory Affairs Manager --- Regulatory Affairs Manager ================================ Regulatory Affairs Manager (M/F) -------------------------------- Regen Lab SA has been dedicated since 2003 to the production of medical devices dedicated to the preparation of autologous blood derivatives (PRP), intended for non-hematological therapeutic applications in the fields of sports medicine, rheumatology, orthopedic surgery, urology, aesthetic medicine, and wound treatment. To strengthen our team based in Mont-sur-Lausanne, we are looking for a Regulatory Affairs Manager with solid regulatory expertise, capable of driving regulatory activities while contributing directly to their operational implementation. ### Your responsibilities * Define, deploy, and implement the regulatory strategy for international markets. * Ensure the compliance of medical devices with applicable regulations and standards, notably the European regulation MDR 2017/745, FDA requirements, and the ISO 13485 standard. * Prepare, write, update, and maintain the technical and regulatory files necessary for the registration and maintenance of medical devices on different markets. * Ensure a significant part of document writing, notably technical files, regulatory reports, compliance justifications, and associated documents. * Drive Post-Market Surveillance (PMS) activities and contribute to the preparation, writing, and updating of Periodic Safety Update Reports (PSUR), in accordance with applicable regulatory requirements. * Ensure the monitoring of registrations, submissions, and regulatory renewals in the concerned markets. * Interact with competent authorities, notified bodies, and external partners. * Participate in change control activities and perform regulatory impact assessments related to modifications of products, processes, or documentation. * Collaborate closely with Quality, R&D, Clinical, and Marketing teams in order to integrate regulatory requirements throughout the life cycle of medical devices. * Ensure proactive regulatory monitoring and support internal teams in understanding and applying current requirements. * Supervise, support, and develop the Regulatory Affairs team, organize priorities, and distribute activities while guaranteeing respect for regulatory deadlines. * Contribute to the recruitment, training, and skill development of the team. ### Your profile * Scientific or engineering training, ideally completed by a specialization in regulatory affairs. * At least 5 years of experience in regulatory affairs in the medical device sector, ideally classes II and III, including implantables. * Proven experience in the preparation and maintenance of technical and regulatory files. * Practical experience in PMS and PSUR, including the writing and updating of associated reports. * Excellent writing skills and ability to produce structured, precise regulatory documentation in compliance with applicable requirements. * Very good mastery of the European regulation MDR 2017/745 and associated quality standards. * Experience with international regulatory submissions and FDA requirements appreciated. * Experience in management or coordination of a Regulatory Affairs team. * Fluent French and English, both written and spoken. * Autonomy, rigor, organizational skills, and the ability to manage several files in parallel. * Practical spirit, proactivity, and the ability to reconcile strategic vision, technical expertise, and operational involvement. ### We offer * A dynamic and innovative environment within the MedTech sector. * International projects with high added value. * A function combining regulatory expertise, managerial responsibilities, and direct operational involvement. * A key role in maintaining regulatory compliance and the international development of our medical devices. * A collaborative culture oriented towards continuous improvement. * Attractive conditions and prospects for evolution. REGEN LAB SA * REGEN LAB SA En Budron B2 1052 Le-Mont-sur-Lausanne * [ ](< >) jpidb60b497jm jpit1042jm jpiy26jm