Senior Consultant - MedTech Regulatory Implementation

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less than a minute ago
Type
Full time
Salary
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Related skills

eu mdr/ivdr rim medtech fda udi

πŸ“‹ 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.

🎯 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.

🎁 Benefits

  • Medical, dental, vision, and basic life insurance.
  • Flexible PTO and company paid holidays.
  • Retirement programs.
  • 1% charitable giving program.
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