Senior Consultant - MedTech Regulatory Implementation
Core
Lead MedTech Regulatory Information Management (RIM) implementations, guiding the transformation of customers' Regulatory Affairs and Operations processes through Veeva's industry cloud technology.
Role type
Senior Consultant (MedTech Regulatory Implementation)
Builds
End-to-end regulatory data and documentation management solutions for MedTech customers
Domain
Life Sciences / MedTech / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Systems Implementation, GxP Systems ownership, Software Consulting, Regulatory Operations, Regulatory Affairs, FDA requirements, EU MDR/IVDR, Technical Documentation structures, UDI reporting standards, IT operations leadership
Preferred skills
Veeva Vault implementation, Change Management, Management Consulting, SaMD, Combination products, Global submission planning
Technologies
Veeva RIM, RegDesk, RIMSYS, IQVIA, Kalypso, Essenvia
Responsibilities
Lead RIM implementation workstreams ensuring customer adoption and system configuration; Review and analyze existing customer business processes to identify gaps and requirements; Function as primary customer liaison managing communication between teams and stakeholders; Analyze requirements to develop long-term adoption and enhancement roadmaps; Guide customers in adopting Veeva RIM and industry best practices for regulatory data and document management
Seniority
Senior, hands-on IC