Solution Architect – Regulatory, RIM

🕒 Outubro 2

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

💻 Engenheiro de Soluções

👻 Score fantasma 18%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 39 dias.
• Sem salário divulgado.

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Kivo

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2021

🏥 Saúde

💼 Consultoria

⚕️ Seguro de Saúde

💰 $3.000.000 Seed Round em 2022-04

Healthcare • Consulting • Healthcare Insurance

A Kivo é uma plataforma de gestão de documentos, conteúdo e processos, compliance, especificamente adaptada para a indústria de ciências da vida. Oferece soluções para Gestão de Documentos (DMS), Arquivo Mestre de Ensaios Eletrônicos (eTMF), Gestão de Informações Regulatórias (RIM) e Gestão da Qualidade (QMS). Projetada para empresas farmacêuticas e de dispositivos médicos, a Kivo ajuda a otimizar fluxos de trabalho, garantir compliance e gerenciar a documentação ao longo de seu ciclo de vida, tudo enquanto oferece acessibilidade e operações fáceis de usar.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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

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