Lead Regulatory Affairs, DB Admin

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences,diagnosticsand biotechnology? 

At Cepheid, one ofDanaher’s15+ operating companies, our work saves lives—andwe’reall united by a shared commitment to innovate for tangible impact.  

You’llthrive 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’llget 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 theDanaher Business Systemwhich 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 Databaseroleoversees regulatory modules within ERP systems (SAP) to control regulatory blocks, approvals, and order release, ensuringon‑timedelivery to customers. Maintainsaccurateand auditable regulatory databases, including global registrations and listings (EUDAMED, PRRC, MHRA), and ensures completeness, accuracy, and traceability of regulatory recordsin accordance withQMS requirements.

This positionreports to theOn Market Sustainment Leader andis part of theQRCOn Market Sustainmentteam and will belocatedonsite inIndia. 

In this role, you will have the opportunity to:

• Provides regional regulatory intelligence andmaintainscurrent regulatory listings (EUDAMED, PRRC, MHRA), ensuring alignment with evolving regulations and guidelines. 

• Manages andmaintainsregulatory data within SAP ERP, including regulatory blocks, releases, andaccuratetracking of blocked/released products to supporttimelycustomer 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, workingcross‑functionallyto enhance regulatory databases, reporting, and system efficiencies. 

• Ensures compliance with QMS requirements throughaccuratedocumentation, 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 experienceorMaster'sdegree 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 alsopossesspreviousexperience 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. Whetherit’sa health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.