Senior Manager, On-Market Substainment

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.

Learn about the which makes everything possible.

The Senior Manager, On-Market Sustainment is responsible evaluating and improving Regulatory Affairs and Cepheid's Quality Management System by employing best practices to ensure compliance to applicable Medical Device and IVD regulations/standards and Danaher Policies. This role has the opportunity to work with other Cepheid sites around the world to build a world-class sustainment program for On-Market Products.

This position is part of the On-Market Sustainment (OMS) team within the Quality, Regulatory and Clinical Affairs Organization, and will be located in Bengaluru, India. The OMS team collaborates with cross-functional business partners to ensure that customer needs are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved.

In this role, you will have the opportunity to:

• Manage OnMarket Sustainment activities assigned to the Indian Development Center (IDC), including Technical Publications and IVDR transition activities
• Oversee execution of IVDR transition deliverables and maintain documentation required for ongoing compliance activities
• Monitor and verify adherence to FDA regulations, EU IVDR requirements, and applicable global regulatory standards for medical devices and diagnostics
• Maintain regulatory compliance records and track updates to global regulatory requirements impacting onmarket products
• Coordinate collection, assembly, and version control of Regulatory Submission documents supporting Market Expansion and Market Protection activities
• Execute crossfunctional regulatory readiness activities to ensure systems, controlled documentation, and training platforms meet audit and inspection requirements
• Maintain auditready regulatory documentation repositories and ensure alignment with internal quality system procedures

The essential requirements of the job include:

• Bachelor's degree in a scientific or engineering discipline with 9+ years of industry experience, or Master's degree with 7+ years of industry experience
• Minimum 2 years of leadership experience in regulated medical device, diagnostics, or life sciences environments
• Proficiency with FDA Quality System Regulation (QSR), ISO 13485, and EU IVDR compliance frameworks
• Direct experience supporting FDA and ISO regulatory audits, inspections, and certification activities
• Demonstrated involvement in process improvement initiatives within regulated medical device, diagnostics, or life sciences operations
• Experience advising or supporting teams executing process improvement activities in compliancedriven environments
• Ability to travel up to 10% for audits, inspections, or operational support

It would be a plus if you also possess:

• 5+ years of department leadership experience in managing both processes, resources, and people in a medical device environment.

Cepheid, a Danaher 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 .

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

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.

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