Solution Architect – Regulatory, RIM

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Collaborate early in the sales process to aid in defining requirements and scoping projects.

• Oversee comprehensive Kivo platform implementations utilizing structured project management and governance.

• Conduct discovery and design workshops.

• Convert regulated process requirements into configured platform solutions, with decisions properly documented.

• Support customer adoption of Kivo.

• Educate clients on Kivo’s validation methodology and guide them through Kivo documentation.

• Collaborate with Data Migration on discovery, field mapping, dry-run coordination, and production cutover checklists.

• Lead 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 main strategic contact following implementation.

• Develop customized success plans that align with customer business objectives.

• Work with Sales to identify, qualify, and pursue expansion and upsell opportunities.

• Foster senior-level customer relationships and provide executive-ready insights, business reviews, and ROI narratives.

• Advocate for customer feedback internally and partner with Product on prioritizing the roadmap, features, and packaged offerings.

• Oversee feature releases and configuration changes to promote adoption and effective platform utilization.

• Take ownership of GRR and NRR metrics; implement playbooks for at-risk accounts, renewals, and expansion discussions with Sales leadership.

⛳️ Requirements

• 5–10+ years of experience in a customer success, implementation, or blended services role within a life-sciences SaaS context.

• Strong expertise in Regulatory Affairs or Operations within the pharmaceutical/biotech or medtech sectors.

• Proven success in managing a portfolio of accounts.

• Familiarity with GxP, 21 CFR Part 11, and Annex 11.

• Comfortable supporting CSA/CSV validation deliverables.

• Experience in leading software implementations in a regulated setting, including project planning, stakeholder management, and go-live execution.

• Exceptional written and verbal communication skills in English.

• Skilled in presenting to both technical users and C-suite stakeholders.

• Based in the US with the ability to occasionally adjust schedules for collaboration on EU-based projects.

• Practical experience with AI models like Claude, ChatGPT, or Copilot to develop workflows, automations, or skills, and the capability to guide customers in their application.

• Bachelor’s degree in computer science or equivalent experience.

• Ability to thrive in a fast-paced environment and manage changing priorities.

• Systems-thinking mindset with a curiosity to understand underlying reasons.

• Strong focus and commitment to customer success.

• Hands-on experience with life-sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or similar eQMS, eTMF, or RIM systems is a plus.

• Experience in hyper-growth environments and possession of PMP, Agile/Scrum certification, or equivalent project management training are advantageous.

🏝️ Benefits

• Ownership of customer success, retention, and expansion.

• Opportunity to establish trusted relationships with customers and serve as a strategic partner.

• Professional growth through hands-on implementation, validation, and work in regulated industries.

• Engage with AI models including Claude, ChatGPT, and Copilot to create workflows, automations, or skills.

• Ability to maintain a healthy work-life balance.