Lead Regulatory Affairs, Db Admin

Danaher

India
Onsite
Sap erp regulatory blocks management
Global regulatory listings maintenance
Eudamed prrc mhra database oversight
Danaher is seeking a Lead Regulatory Affairs professional to oversee regulatory modules within ERP systems at Cepheid, focusing on ensuring compliance and efficient product delivery in life sciences and diagnostics. The role emphasizes maintaining accurate regulatory databases and driving continuous improvement initiatives within a collaborative, mission-driven environment

Job Summary

  • This role oversees regulatory modules within SAP ERP to control blocks, approvals, and order release ensuring on-time delivery.
  • The position requires maintaining accurate and auditable regulatory databases including global registrations in EUDAMED, PRRC, and MHRA.
  • Candidates will drive continuous improvement initiatives using the Danaher Business System while ensuring strict compliance with QMS requirements.

Matching Summary

Match Score: 85

Danaher is seeking a Lead Regulatory Affairs professional to oversee regulatory modules within ERP systems at Cepheid, focusing on ensuring compliance and efficient product delivery in life sciences and diagnostics. The role emphasizes maintaining accurate regulatory databases and driving continuous improvement initiatives within a collaborative, mission-driven environment.

Skills & Requirements

Must-have

  • SAP ERP regulatory blocks management
  • Global regulatory listings maintenance
  • EUDAMED PRRC MHRA database oversight
  • QMS compliance documentation
  • IVD diagnostics registration processes

Nice-to-have

  • Continuous improvement initiatives using DBS
  • Commercial product lifecycle strategies
  • Market access planning experience
  • Cross-functional collaboration skills

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 EU MDR, IVDR, FDA, Health Canada, and PMDA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter