Lead Regulatory Affairs - DB Admin

Role Overview Cepheid, a Danaher operating company, is seeking a Lead Regulatory Affairs professional for Business Enablement Database management to join the QRC On-Market Sustainment team in Bengaluru. This role is central to governing regulatory data, enterprise systems, and business processes that ensure compliant product identification, registration, and timely global market release. You will work within a culture of continuous improvement and innovation, contributing directly to solutions that improve healthcare outcomes worldwide. Key Responsibilities - Oversee regulatory modules within SAP ERP systems to manage regulatory blocks, approvals, and order release, supporting on-time customer delivery - Maintain accurate and auditable regulatory databases including global registrations and listings such as EUDAMED, PRRC, and MHRA - Manage and support regulatory software tools including SAP, TrackWise, and BI tools covering validation, documentation management, and registration tracking - Provide regional regulatory intelligence and ensure listings remain aligned with evolving international regulations and guidelines - Drive continuous improvement initiatives using DBS tools and work cross-functionally to enhance database efficiency and reporting capabilities - Ensure compliance with QMS requirements through accurate documentation, SOP maintenance, standard work execution, and thorough data completeness reviews Required Qualifications - Bachelor's degree in a relevant field with at least 5 years of related work experience, or a Master's degree with a minimum of 3 years of experience - Demonstrated experience managing regulatory data and listings within enterprise systems such as SAP ERP including regulatory blocks and product compliance tracking - Ability to interpret and apply global regulatory requirements including EU MDR, IVDR, FDA, Health Canada, and PMDA - Familiarity with global regulatory frameworks and product registration processes within IVD diagnostics - Prior experience with commercial product lifecycle strategies and market access planning is an added advantage Why Join Us Cepheid offers a comprehensive benefits package and a collaborative work environment where your unique perspective matters. This is an opportunity to make a measurable global impact within the life sciences and diagnostics sector while advancing your career through Danaher's proven system of continuous improvement.

- Bachelor's degree with 5 plus years or Master's degree with 3 plus years of relevant experience - Experience managing regulatory data within SAP ERP including regulatory blocks and product compliance tracking - Knowledge of global regulatory requirements such as EU MDR, IVDR, FDA, Health Canada, and PMDA - Familiarity with IVD diagnostics regulatory frameworks and product registration processes - Experience with regulatory tools such as TrackWise and BI reporting tools - Understanding of QMS requirements, SOP maintenance, and standard work execution - Familiarity with commercial product lifecycle strategies and market access planning is a plus

- Comprehensive health care programs - Paid time off and leave benefits - Career growth and development opportunities - Exposure to global regulatory and life sciences environment - Work within Danaher's continuous improvement ecosystem