About the CompanyBring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At 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. You’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.Masimo 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. Learn about the Danaher Business System which makes everything possible.About the RoleThe Sr Manager, Quality and 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.The 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.This 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.Key ResponsibilitiesIn this role, you will have the opportunity to:Lead RA/QA operations strategy and execution to support compliance and business growthDrive regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentationOversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory recordsSupport implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirementsManage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readinessRequired qualificationsThe essential requirements of the job include:8-12+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industryStrong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworksHands-on experience with EUDAMED and UDI implementation in alignment with global frameworksStrong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processesFluent in English, any other language is a plus.Preferred qualificationsIt would be a plus if you also possess previous experience in:Patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies3-5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teamsWorking in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operationsBenefitsMasimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.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. For more information, visit is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. #J-18808-Ljbffr
Sr Manager, Quality and Regulatory Operations in Neuenburg am Rhein Arbeitgeber: Radiometer
Beckman Coulter Diagnostics bietet eine herausragende Arbeitsumgebung, in der Innovation und Teamarbeit im Mittelpunkt stehen. Als Teil eines globalen Unternehmens in München haben Sie die Möglichkeit, an bedeutenden Projekten in der Medizintechnik zu arbeiten, während Sie von einem unterstützenden Team profitieren, das Ihre berufliche Entwicklung fördert. Mit einem starken Fokus auf kontinuierliche Verbesserung und einer Kultur der Zugehörigkeit sind wir bestrebt, nicht nur die Lebensqualität der Patienten zu verbessern, sondern auch die Ihrer Mitarbeiter.
