Regulatory Solution Architect for Life Sciences

Kivo, Inc.

Boston, Northern (MA, KY)

Hybrid

USD 150,000 - 210,000

Full time

9 days ago
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Job summary

Kivo, Inc. is seeking a Solution Architect to own the post-sale journey for pharma/biotech customers. You will lead hands-on implementations, drive customer outcomes, and partner with Success to ensure retention and expansion.

In this senior, customer-facing role, you will manage engagements in regulated environments (GxP, 21 CFR Part 11/Annex 11) and collaborate with US teams, with occasional EU support. Remote-work options not specified; US-based position with flexibility.

Qualifications

  • 5–10+ years in customer success, implementation, or blended services in life-sciences SaaS.
  • Strong domain knowledge in Regulatory Affairs or Operations for pharma/biotech/medtech.
  • Experience managing a portfolio of accounts.
  • Knowledge of regulated requirements (GxP, 21 CFR Part 11 / Annex 11) and validation deliverables.
  • Experience leading software implementations in regulated environments; project planning & go-live delivery.
  • Excellent English communication; comfortable with C-level presentations.
  • Based in the US with occasional EU collaboration.
  • Applied AI experience with AI models to build workflows or automations.

Responsibilities

  • Lead end-to-end implementations of the Kivo platform with structured project management and governance.
  • Design and configure solutions translating regulated requirements into platform configurations.
  • Support validation workstreams & data migration coordination.
  • Guide go-live activities and post-go-live stabilization.
  • Own account health and manage NA portfolio post-implementation.
  • Identify expansion opportunities in partnership with Sales.
  • Deliver executive-ready insights and ROI narratives.
  • Manage upgrades, adoption, and drive retention and growth.

Skills

Customer success leadership
Implementation project management
Regulatory affairs knowledge
English communication
AI model experience

Education

Bachelor’s degree in computer science or equivalent

Job description

Kivo, Inc. is seeking a Solution Architect to own the post-sale journey for pharma/biotech customers. You will lead hands-on implementations, drive customer outcomes, and partner with Success to ensure retention and expansion.

In this senior, customer-facing role, you will manage engagements in regulated environments (GxP, 21 CFR Part 11/Annex 11) and collaborate with US teams, with occasional EU support. Remote-work options not specified; US-based position with flexibility.

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