Regulatory Affairs Program Manager

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 Regulatory Affairs Program Manager is responsible for planning and coordinating the execution of the required post launch activities within Regulatory Affairs for sustaining the Technical Documentation for the CE IVDR portfolio. The planning is performed in cooperation with the head of RA IVDR sustainment and in collaboration with cross-functional teams.

This position is part of the Regulatory Affairs Global Market Protection – IVDR Sustainment and will be located in UK-Remote. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Coordination of the execution of RA IVDR sustainment activities in alignment with functional goals and business objectives to maintain IVDR compliance.

• Fosters effective and productive communication among Regulatory Affairs sub-teams and cross-functional teams by acting as a liaison and facilitator to develop and implement strategy according to program priorities.

• Interprets internal or external business issues, leads identification and resolution of program blocks using problem solving skills and recommend strategy for IVDR sustainment.

• Serve as an IVDR Regulatory Subject Matter Expert (SME) and assisting RA leads in resolving issues support cross-functional teams. Provide mentorship and coaching to RA lead and cross-functional training.

• Work in a global environment with cross-functional teams at different sites.

The essential requirements of the job include:

• Bachelor’s degree in field with 8+ years of related work experience or Master's degree in field with 6+ years of related work experience

• 3+ year experience of working with EU IVDR/MDR and technical documentation.

• 2+ year experience from project management

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

• People management

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.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

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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