Senior Regulatory Affairs Specialist

Job TitleSenior Regulatory Affairs SpecialistJob DescriptionIn this role, you have the opportunity toEnsure that products comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions, and enablers for SaMD products supporting the Cardiologs business within Ambulatory Monitoring and Diagnostics (AM&D). The Sr. Regulatory Affairs Specialist is responsible for preparing comprehensive regulatory strategies for complex software devices and significant post market changes and international expansion into new markets.You are responsible forManagement of Regulatory submission deliverablesPoint of contact for Regulatory activities with internal and external stakeholdersParticipate actively in QMS improvement. Seek and drive continuous improvement initiativesReview and interpret regulatory guidelines and keep up to date with US, EU and global market regulations and communication in an organized mannerAuthor and submit US 510(k), EU MDR Technical File and global/international submissionsStrategize clinical needs and support clinical study planning and executionSupport internal and external audits (CE, FDA, MDSAP, global audits)Gather requirements and documentation and help build regulatory guidance and strategy in US and global regionsCollaborate with the Commercial team to ensure support is provided and products remain in compliance with applicable regulations and internal proceduresProvide regular trainings to the teamManage Product change control process: Ensure product compliance: guarantee that regulatory requirements are met in regard to local and international regulations and company standards. Maintain & update of technical files and necessary documentation for product release. Responsible for release of the product.You are a part ofThe Cardiologs team, which is part of the Ambulatory Monitoring & Diagnostics Group (AM&D), reflecting its powerful position in patient care management in ambulatory and home care settings. Building on its strength in ambulatory electrocardiography, diagnostics, and mobile monitoring, you will be part of the team that will expand its service offerings and geographic reach.To succeed in this role, you’ll need a customer-first attitude and the followingInterested in cutting-edge technology and software in the medical device industryHas a bachelor/master’s degree in engineering, law, life sciences, pharmacy, medicine, or another relevant disciplineQuick learnerOrganized, rigorous, committed, and enthusiasticIndependent and rigorous but still quite creative, flexible, and pragmaticObjective-oriented and able to deliver results within the expected deadlinesFluent in both written and spoken English5+ years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.).Strong background in Design Controls.Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards.Experience in supporting international registrations and/or clinical investigations.Proficient computer skills in Microsoft Office.Understand LEAN concepts, methodologies and deployment.May require 10% travel annually with possibly some international.About PhilipsWe 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.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. #J-18808-Ljbffr