Associate Director Regulatory Affairs - Combination Products

Green Life Science are working with a leading global medtech organisation that is shaping the future of injection and drug delivery technologies. With billions of devices manufactured annually across multiple international sites, this is a fantastic opportunity to step into a strategic leadership role at the heart of their global operations. In this position, you’ll be responsible for driving regulatory initiatives for marketed products, ensuring world-class compliance, and delivering customer excellence. You’ll play a pivotal role in leading regulatory dossiers, supporting international expansion, and coordinating cross-functional collaboration across RA, R&D, and Quality. Key Responsibilities: Lead, mentor and develop a high-performing regulatory affairs team. Oversee all regulatory activities for marketed products to maintain compliance and strengthen customer partnerships. Champion customer excellence, ensuring regional support and creating long-term value. Review and approve promotional materials in line with regulatory requirements. Train internal teams on European and US (FDA) regulatory frameworks. Manage regulatory registrations and updates, and prepare teams for agency interactions. About You: Experienced leader in Regulatory Affairs with proven strategic and operational expertise. Background in pharmaceuticals, medical devices, and ideally combination (drug-device) products. Strong track record of regulatory submissions and authority engagement. In-depth knowledge of US FDA regulations, GxP and QSR. Skilled communicator, motivator, and project manager, comfortable in global and matrix environments. If you’re ready to take on a global leadership role in regulatory affairs and drive excellence across compliance, innovation, and customer success – I’d love to hear from you. Apply today or reach out directly to discuss further.

Location: Grenoble, FR

Posted Date: 10/30/2025