At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Principle Regulatory & Quality Lead will collaborate cross-functionally with business partners to drive regulatory compliance in change management and design control. The incumbent has the ability to innovate, communicate and execute strategic process and organizational improvements, drive results independently and in a matrix-team environment and is willing to solve complex problems to meet business obligations on-time. 

This position is part of the Regulatory Affairs Global Market Protection team and will be located in Solna. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Act as RA lead on post-launch change projects through assessment of global regulatory impact and notification of ARMs and/or submission of changes to regulatory agencies (e.g. WHO, BSI, ROW)Collaborate with team to review changes with substantial regulatory impact that may require reporting or notification.Audit and evaluate current policies, procedures, and documentation for compliance with global regulations and statutes.Support the Global RA organization by giving strategic input to process improvements, departmental compliance activities and feedback to draft guidance’s within design & change control and risk managementCollaborate globally and cross-functionally (e.g. Post-Market Quality, Risk Management, Research & Development, Clinical Affairs, Quality Engineering) to drive and support continuous improvementEvaluate existing roles, responsibilities and processes in Regulatory Affairs and Quality to identify synergies and opportunities for improvementLead process improvements and implementation to enable effective IVDR sustainmentLead initiative to foster collaboration and knowledge sharing between RA & QA, enhancing mutual learning to drive operational efficiencySupport organizational improvements to establish an effective sustainment organizationEnsure change control compliance by serving as RA & QA liaison for change management, supporting the implementation of parallel and cumulative change assessment process and providing training to change control stakeholders

The essential requirements of the job include:

Bachelor's degree with 8+ years of related work experience in regulatory affairs or QA&RA functions or Master's degree in field with 6+ years of related work experience regulatory affairs or QA&RA functionsUnderstands Regulatory Affairs concepts and is familiar with regulations/guidelines governing development of IVD diagnostic products.Extensive working knowledge and application of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products.Extensive working knowledge and application of ISO 13485 for quality management systems, ISO 14971 for risk management, and ISO 18113 for labeling requirementsAbility to succeed in a fast-paced environment with the ability to be flexible and adaptable within a dynamic environment

It would be a plus if you also possess previous experience in:

Prior knowledge of Product Lifecycle management applicationsWorking knowledge of Post Market Surveillance standardsExperience with continuous improvements to change management and change impact processes.

Cepheid, 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 danaherbenefitsinfo.com.

Join 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 www.danaher.com.

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