The Böblingen site is a key location for Philips’ Patient Monitoring business category which is part of the Hospital Patient Monitoring business.The Hospital Patient Monitoring-NPI RA department is responsible for EU, US, and Global submissions and registrations for all medical devices which are manufactured by or for HPM-NPI . **Your role:** + Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy for new product introduction + Responsible for worldwide product registration submissions/approvals as well as license renewals and updates. + Prepare FDA and Health Canada submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions. + Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed + Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements. + Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations + Provide Regulatory support for Audit, IIA and CAPA **You're the right fit if:** + Technical degree in engineering or scientific discipline -such as Biomedical Engineering, with clear understanding of the multimodality systems + 2-3 years´ plus professional experience in medical device product Quality or Regulatory, R&D, -specially dealing with regulatory aspects product development, design control related deliverables + First professional experience in regulatory affairs or in quality management systems related to medical devices. + Knowledge of regulatory standards (e.g. IEC 60601 series, IEC 62304, IEC 62366, ISO 14971) + Experience working with technical documentation under MDD and MDR beneficial + Fluent in English + Cross-functional influence and advisory experience is helpful **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 onsite role. \# LI-EU **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 commitment to diversity and inclusion here.