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Kivo

Solution Architect – Regulatory, RIM

Kivo

. Engage early in the sales process to assist with requirements definition and project scoping .

Posted 10/2/2026full-timeRemote • Massachusetts • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing customer success and implementation processes within life-sciences SaaS environments, with a strong focus on regulatory compliance and customer adoption strategies. Proficient in leading software implementations, stakeholder management, and delivering tailored success plans aligned with customer business goals.

Highest-signal resume keywords
Customer Success ManagementRegulatory Affairs KnowledgeGxP ComplianceSoftware Implementation LeadershipApplied AI Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Project ManagementStakeholder ManagementGo-Live DeliveryField MappingChange ManagementDefect TriageUser Training EnablementSystems-Thinking MindsetCustomer Adoption StrategiesDocumentation of Decisions
Soft Skills
Excellent Communication SkillsPresentation SkillsRelationship BuildingAdaptabilityCustomer Focus
Tools & Technologies
Kivo PlatformVaultMasterControlTrackWise/ETQEQMSETMFRIM Systems
Certifications & Qualifications
PMP CertificationAgile/Scrum Certification
Industry Keywords
Life-Sciences SaaSPharmaceuticalBiotechMedtech21 CFR Part 11Annex 11CSA/CSV Validation

Tech Stack

Tools & technologies
PMPVault

About the role

Key responsibilities & impact
  • Engage early in the sales process to assist with requirements definition and project scoping
  • Lead end-to-end Kivo platform implementations through structured project management and governance
  • Facilitate discovery and design workshops
  • Translate regulated process requirements into configured platform solutions with documented decisions
  • Guide customer adoption of Kivo
  • Educate customers on Kivo’s validation methodology and orient them to Kivo documentation
  • Partner with Data Migration on discovery, field mapping, dry-run coordination, and production cutover checklists
  • Guide change management, defect triage, go-live readiness assessments, user training enablement, and post-go-live stabilization
  • Manage a portfolio of North American accounts as the primary strategic post-implementation contact
  • Build tailored success plans aligned with customer business goals
  • Partner with Sales to identify, qualify, and advance expansion and upsell opportunities
  • Cultivate senior customer relationships and deliver executive-ready insights, business reviews, and ROI narratives
  • Represent customer feedback internally and collaborate with Product on roadmap priorities, features, and packaged offerings
  • Manage feature releases and configuration changes to ensure adoption and platform utilization
  • Own GRR and NRR metrics; execute playbooks for at-risk accounts, renewals, and expansion conversations with Sales leadership

Requirements

What you’ll need
  • 5–10+ years of experience in a customer success, implementation, or blended services role within a life-sciences SaaS environment
  • Strong domain knowledge in Regulatory Affairs or Operations for pharmaceutical/biotech or medtech industries
  • Demonstrated track record managing a portfolio of accounts
  • Working knowledge of GxP, 21 CFR Part 11, and Annex 11
  • Comfort supporting CSA/CSV validation deliverables
  • Experience leading software implementations in a regulated environment, including project planning, stakeholder management, and go-live delivery
  • Excellent written and verbal communication skills in English
  • Comfortable presenting to technical users and C-suite stakeholders
  • Based in the US with flexibility to occasionally time-shift for EU-based project collaboration
  • Applied AI experience with models such as Claude, ChatGPT, or Copilot to build workflows, automations, or skills, and ability to guide customers in their use
  • Bachelor’s degree in computer science or equivalent experience
  • Ability to work in a fast-paced environment and manage shifting priorities
  • Systems-thinking mindset and curiosity to understand the “why”
  • Focus and commitment to customer success
  • Hands-on experience with life-sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or comparable eQMS, eTMF, or RIM systems is nice to have
  • Prior hyper-growth experience and PMP, Agile/Scrum certification, or equivalent project management training are nice to have

Benefits

Comp & perks
  • Customer success, retention, and expansion ownership
  • Opportunity to build trusted customer relationships and serve as a strategic partner
  • Professional development through hands-on implementation, validation, and regulated-industry work
  • Work with AI models including Claude, ChatGPT, and Copilot to build workflows, automations, or skills
  • Ability to maintain a balance outside the office