Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact .
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.
At Cepheid, we are passionate about improving health care through fast, accurate , molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The QRC On-market Sustainment team leads the governance, execution, and continuous improvement of regulatory data, systems, and business processes to ensure compliant product identification, registration, and release across global markets .
The Lead Regulatory Affairs , Business Enablement Database role oversees regulatory modules within ERP systems (SAP) to control regulatory blocks, approvals, and order release, ensuring on ‑ time delivery to customers. Maintains accurate and auditable regulatory databases, including global registrations and listings (EUDAMED, PRRC, MHRA), and ensures completeness, accuracy, and traceability of regulatory records in accordance with QMS requirements.
This position reports to the On Market Sustainment Leader and is part of the QRC On Market Sustainment team and will be located onsite in India .
In this role, you will have the opportunity to:
+ Provides regional regulatory intelligence and maintains current regulatory listings (EUDAMED, PRRC, MHRA), ensuring alignment with evolving regulations and guidelines.
+ Manages and maintains regulatory data within SAP ERP, including regulatory blocks, releases, and accurate tracking of blocked/released products to support timely customer delivery.
+ Owns and supports regulatory databases and software tools (e.g., SAP, TrackWise, BI tools), including validation, documentation management, and registration tracking.
+ Drives continuous improvement initiatives using DBS tools, working cross ‑ functionally to enhance regulatory databases, reporting, and system efficiencies.
+ Ensures compliance with QMS requirements through accurate documentation, proper filing, SOP maintenance, standard work execution, and data completeness reviews.
The essential requirements of the job include:
+ Bachelor’s degree in field with 5+ years of related work experience or Master’s degree in field with 3+ years of related work experience
+ Demonstrated experience managing regulatory data and listings within enterprise systems (e.g., SAP ERP) including regulatory blocks, releases, and product compliance tracking.
+ Ability to interpret and apply global regulatory requirements (EU MDR, IVDR, FDA, Health Canada, PMDA, etc.)
+ Familiarity with global regulatory frameworks and product registration processes within IVD diagnostics.
It would be a plus if you also possess previous experience in:
+ Familiarity with commercial product lifecycle strategies and market access planning
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 Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
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 .
Operating Company: Cepheid
