Senior Consultant - MedTech Regulatory Implementation

Added
less than a minute ago
Type
Full time
Salary
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Related skills

software implementation gxp veeva vault mdr rim

πŸ“‹ Description

  • Lead RIM implementation workstreams for MedTech regulatory solutions.
  • Review customer processes to identify steps, gaps, and requirements.
  • Serve as primary customer liaison; manage communications among teams.
  • Analyze requirements and features to build adoption roadmaps for Regulatory Operations.
  • Guide customers in adopting Veeva RIM and best practices for regulatory data and docs.

🎯 Requirements

  • 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting.
  • 4+ years in Regulatory Operations or Regulatory Affairs in Medical Device/Diagnostics.
  • Direct experience with software implementation for Veeva RIM or similar solutions.
  • Strong understanding of global regulatory requirements including FDA, EU MDR/IVDR, and UDI.
  • Proven track record leading IT operations or implementations as a consultant, business analyst, or sponsor.
  • Excellent verbal and written communication with ability to design creative solutions for complex requirements.

🎁 Benefits

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