Solution Architect – Regulatory, RIM

Job not on LinkedIn

🔥 3 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💻 Solutions Engineer

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Kivo

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2021

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

💰 $3M Seed Round on 2022-04

Healthcare • Consulting • Healthcare Insurance

Kivo is a compliant document, content, and process management platform specifically tailored to the life science industry. It offers solutions for Document Management (DMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management (QMS). Designed for pharmaceutical and medical device companies, Kivo helps streamline workflows, ensure compliance, and manage documentation throughout its lifecycle, all while providing affordability and user-friendly operations.

📋 Description

• 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

• 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

• 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