James Wartman

About James Wartman

Forward-thinking leader with extensive management experience building and executing global strategies for multinational MedTech and Pharmaceutical companies. Proven track record of generating significant results within rapidly changing and increasingly complicated health science regulatory landscape. Skilled in building productive working relationships with people across all cultures, functions, and levels of the organization. Broad knowledge of global regulations for medical devices, quality systems, and clinical operations. Strategic Leader – My unique blend of experience (Operations, Lean/Kaizen, Regulatory Affairs, Quality Assurance, Hands-on Project Leader, Global Business and Executive Leadership) has equipped me to think and act strategically. I start with a clear and accurate understanding of the current state, align with key stakeholders on optimum future state, and then I map the most efficient route forward.Coach – My leadership/management style is to coach my teams, leveraging talent to maximize contribution. I have learned to creatively lead people so that they are setup for success. Deliver Value - It\'s never enough to maintain a team or a process. I have learned how to work with stakeholders and partners to identify the optimum value proposition for my teams such that we deliver real value that impacts the business. Quality & Regulatory - I have held multiple global leadership roles in both Quality Assurance and Regulatory Affairs. Building effective and efficient teams, while delivering value and results.M&A - Representing both RA & QA, I have the unique experience of leading small and large projects, including acquisitions, mergers, and divestitures. My involvement would start in due diligence and conclude as the business is effectively transferred. Expertise- Global Regulatory Strategy & Leadership - Acquisitions, Mergers, & Divestitures- Remediation & Process Improvement - Global Quality Systems & Leadership- Cross-Functional Collaboration- Transformation, Team Building, & Reorganization - US FDA Regulations- Clinical Operations- Startup support- Consulting

Experience

1. Principal Consultant for Quality Systems, Regulatory & Clinical Operations at Leansense Solutions

   Leansense Solutions

   Jan 2025 — Present

   As an independent consultant in Regulatory Affairs, Quality Systems, and Clinical Operations, I help early- and growth-stage MedTech companies build the strategies and systems needed to advance novel technologies through the produce lifecycle. My work focuses on defining clear regulatory pathways, establishing scalable QMS structures, and ensuring clinical programs are compliant, efficient, and inspection-ready.Recent engagements include leading regulatory, quality, and clinical strategy for an ophthalmic combination device conducting OUS Proof-of-Concept (PoC) studies. I managed regulatory submissions in multiple countries, built an ISO 13485–aligned QMS, and oversaw full clinical operations across sites in Asia Pacific and Latin America. This included site qualification, CRO and CRC oversight, TMF development, protocol alignment, and continuous risk mitigation to maintain compliance and schedule.I also developed a regulatory and clinical roadmap supporting early PoC data generation, FDA interaction planning, and IDE readiness. Additional work includes advising startups developing AI-enabled technologies for life sciences integration, focusing on regulatory classification, data integrity, and quality expectations. I provide VC partners with due diligence assessments to evaluate regulatory feasibility, clinical readiness, and risk exposure.Across all projects, I apply Lean principles to reduce delays, simplify processes, and improve execution. Clients value my ability to blend strategic insight with hands-on leadership, ensuring programs progress efficiently and remain well-positioned for regulatory and clinical success.

Education

• San Diego State University

  Coursework towards Master of Science (MS) Regulatory Affairs, Regulatory Affairs

  2008 — 2010

• Long Beach State University-California State University

  Bachelor of Science (BS), Operations Management, Operations Management

  1986 — 1989

Skills

• Quality Assurance
• Process Improvement
• Management
• Regulatory Affairs
• Lean Manufacturing
• Iso 13485
• Cross-Functional Team Leadership
• Quality System
• Product Launch
• Validation
• Medical Devices
• Clinical Research
• Capa
• Fda
• Product Development
• U.s. Food and Drug Administration (Fda)
• Gmp
• Design Control
• Corrective and Preventive Action (Capa)