Specialist, Regulatory Affairs

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 Specialist, Regulatory Affairs is responsible fortaking ownership of EU regional product registrations, ensuring that regulatory requirements are effectively managed and that submissions and registrations are completed accurately and within established timelines. Working within a highly collaborative, international organization, the Regulatory Affairs Specialist will liaise closely with cross functional stakeholders as well as regulatory affairs associates across EU and wider global regulatory affairs teams. /p pThis position reports to the Sr Manager, Regulatory and is part of the Regulatory Affairs team located in Neuchâtel, Switzerland and will be an on-site role. /p h3In this role, you will have the opportunity to: /h3 ul liPreparation and submission of national regulatory applications in the EU region /li liProcess and maintain EU registrations/notifications, renewals, changes, other regulatory activities such as EUDAMED registration /li liProcess and maintain requests to complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc. /li liMaintain published regulatory records and databases in SharePoint, Salesforce and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented. /li liSupport customer service, marketing, and sales with global market approvals for product shipments. /li /ul h3The essential requirements of the job include: /h3 ul liExperienced in EU regulatory requirements for CE-marked medical devices and ISO 13485 and EN ISO 14971 requirements /li li2-5 years of EU regulatory work experience in a medical device company. /li liProficient in document control systems, such as SharePoint and Oracle Agile PLM. /li liExperience in global regulatory such as FDA, UKCA and other /li /ul h3It would be a plus if you also possess previous experience in: /h3 ul liPrior experience working with international corporations. /li liDemonstrating ability to work with non-local and local leadership /li liDocumentation skills including record maintenance/ tracking and understanding of document traceability. /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