Regulatory Affairs Project Manager at Philips · Alajuela

Regulatory Affairs Project Manager Location: Alajuela Job Title Regulatory Affairs Project Manager Job Description Regulatory Affairs Project Manager Your role: •Lead and drive global regulatory strategy and execution for new product introductions and lifecycle management activities within the Ambulatory Monitoring & Diagnostics business. • Act as the regulatory lead on cross‑functional project teams, ensuring alignment between product development activities and applicable regulatory requirements. • Manage and drive regulatory projects in close partnership with program management, R&D, Clinical, and commercial teams to enable timely market access. • Serve as the primary point of contact for regulatory project execution and project-related regulatory support. • Assess regulatory impacts of product changes and support change management activities, including global registration updates. • Identify regulatory risks and proactively develop mitigation strategies to support successful regulatory approvals. • Monitor evolving global regulatory requirements and provide strategic guidance on their impact to products, programs, and the broader business. • Lead projects related to new or changing regulatory requirements, internal process improvements, project-specific needs, and general administrative support. • Maintain clear, transparent communication regarding project status, risks, dependencies, and timelines with project teams and leadership. You are the right fit if: • Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field. • 5+ years of experience in Regulatory Affairs and/or project management within medical devices, digital health, or the healthcare industry. • Strong working knowledge of global regulatory frameworks, including FDA regulations (21 CFR), EU MDR/IVDR, and international regulatory requirements. • Proven experience defining, executing, and delivering regulatory strategies and regulatory projects. • Demonstrated ability to manage multiple priorities concurrently and effectively influence cross‑functional, matrixed teams. • Strong communication and stakeholder management skills, with the ability to translate regulatory requirements into clear, actionable plans. • Solid project and resource management capabilities, with strong execution and organizational skills. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.