Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?Together with Danaher’s 15+ other operating companies, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.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.HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count.The Manager Regulatory Affairs for HemoCue is responsible for implementing regulatory processes across global markets and supporting HemoCue teams to ensure patient safety through compliance excellence.This position is part of the RAQA team, located at HemoCue HQ, in Ängelholm, Sweden and will be on-site.At HemoCue, our purpose is clear: advancing care, test by test, everywhere. Care is the bedrock upon which we stand. It’s manifested in our devices, our people and how we interact with the world.You will be a part of the leadership team of RAQA at HemoCue and report to the Sr Director RAQA. If you thrive in a customer focused, fast-paced, collaborative environment and are passionate about leadership and want to work to build a world-class regulatory organization—read on.In this role, you will have the opportunity to:Lead regulatory strategy, compilation of regulatory submissions & product registrationsManage activities, resources and personnel within the Regulatory Affairs teamEnsure product compliance with regulatory and internal requirements for the Quality Management SystemServe as the regulatory point of contact for health authorities and notified bodies. Act as Person Responsible for Regulatory Compliance.Collaborate cross-functionally in all relevant R&D, Operations, Marketing, and Sales activities to support product development and lifecycle managementSupport the organization in regulatory monitoring, interpretation, regulatory intelligence and communication of regulations to stakeholdersLeading associates within the RA team to drive engagement and continuous improvements to ensure it is a competitive advantage for the businessThe essential requirements of the job include:University Degree in Science or TechnologyMinimum 5 years of experience from Quality and Regulatory ManagementMinimum 3 years of management experience or proven leadership personalityExcellent understanding and in-depth knowledge of regulatory demands for Medical Device/IVDs including ISO13485 and QSR as well as relevant standards and regulations in Canada, Brazil, Japan, Australia and other key markets (FDA, ISO and IVDR)English – fluent verbally and in writing, and preferable Scandinavian – fluent verbally and in writingReview and analyze quality and regulatory performance data to identify trends and areas of improvementIt would be a plus if you also possess previous experience in:Planning, execution and management of auditsExcellent problem-solving skillsJoin a 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.Union contacts: Henrik Pommer, Unionen, +46 431 481 244 or Katarina Cooper, Akademikerföreningen, +46 431 481 302For more information, visit .DanaherJoin 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.For more information, visit .
