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software implementation gxp veeva vault mdr rimπ 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.
π― 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.
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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