Danaher UK is seeking a Lead Regulatory Affairs, Business Enablement Database professional to oversee regulatory modules within ERP systems, ensuring compliance and timely delivery of products in the life sciences and diagnostics sectors. The position requires substantial experience in managing regulatory data and familiarity with global regulations, emphasizing the company's commitment to innovative healthcare solutions
Job Summary
This role oversees regulatory modules within SAP ERP systems to control blocks, approvals, and order release for timely customer delivery.
The position requires maintaining accurate global registrations and listings across frameworks like EUDAMED, PRRC, and MHRA in alignment with evolving regulations.
Candidates will drive continuous improvement initiatives using the Danaher Business System while ensuring strict compliance with Quality Management System requirements.
Matching Summary
Match Score: 85
Danaher UK is seeking a Lead Regulatory Affairs, Business Enablement Database professional to oversee regulatory modules within ERP systems, ensuring compliance and timely delivery of products in the life sciences and diagnostics sectors. The position requires substantial experience in managing regulatory data and familiarity with global regulations, emphasizing the company's commitment to innovative healthcare solutions.
Skills & Requirements
Must-have
SAP ERP regulatory data management
Global regulatory listings maintenance
EU MDR IVDR FDA compliance knowledge
QMS documentation and SOP execution
Database validation and traceability
Nice-to-have
Continuous improvement using DBS tools
Commercial product lifecycle strategy experience
Cross-functional collaboration skills
TrackWise software familiarity
BI tools proficiency
Key Requirements
Bachelor's degree with 5+ years experience or Master's with 3+ years
Experience managing regulatory data in enterprise systems like SAP
Knowledge of global regulatory frameworks including EU MDR and IVDR