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eu mdr/ivdr rim medtech fda udiπ Description
- Lead RIM implementation workstreams for MedTech Regulatory solutions.
- Review and analyze customer processes to identify gaps and requirements.
- Serve as primary customer liaison; coordinate with implementation teams, stakeholders, and third parties.
- Analyze requirements and new features to develop adoption roadmaps for Regulatory Operations.
- Guide customers in adopting Veeva RIM and best practices.
π― Requirements
- 8+ years in systems implementation, GxP, or software consulting.
- 4+ years in Regulatory Operations/Affairs in Medical Device/Diagnostics.
- Direct experience with Veeva RIM or similar (RegDesk, RIMSYS, IQVIA).
- Strong understanding of FDA, EU MDR/IVDR, UDI.
- Proven track record leading IT ops/implementations; strong comms.
- Nice to Have: Vault implementation, Change Management, MedTech product experience, UDI planning.
π Benefits
- Medical, dental, vision, and basic life insurance.
- Flexible PTO and company paid holidays.
- Retirement programs.
- 1% charitable giving program.
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