Sr Manager, Quality & Regulatory Operations

pbBring more to life. /b /p pAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? /p pAt Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. /p pYou’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. /p pMasimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others. /p pLearn about the Danaher Business System which makes everything possible. /p pThe Sr Manager, Quality Regulatory Operations will lead regulatory and quality operations to support compliance, market access, and commercial success. This role combines regulatory expertise with quality systems leadership to ensure products, processes, and documentation meet EU and global requirements. /p pThe individual will act as a key partner to Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory and quality requirements, identify gaps, and implement practical solutions. This role requires strong expertise in medical device regulatory frameworks, quality systems, labeling, and post-market compliance, along with the ability to drive operational excellence and audit readiness /p pThis position reports to the Sr Director, Quality Regulatory Strategy and is part of the Quality Compliance team located in Neuchâtel, Switzerland and will be an on-site role. /p h3In this role, you will have the opportunity to: /h3 ul liLead RA/QA operations strategy and execution to support compliance and business growth /li liDrive regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentation /li liOversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory records /li liSupport implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirements /li liManage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readiness /li /ul h3The essential requirements of the job include: /h3 ul li8-12+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry /li liStrong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworks /li liHands‑on experience with EUDAMED and UDI implementation in alignment with global frameworks /li liStrong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processes /li liFluent in English, any other language is a plus. /li /ul h3It would be a plus if you also possess previous experience in: /h3 ul liPatient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies /li li3-5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teams /li liWorking in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operations /li /ul pJoin our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. /p pFor more information, visit /p #J-18808-Ljbffr