Global Medical Device Market Expansion Lead

Ventures Unlimited, Inc.; West Chester (Chester County); On-site; USD 120,000 - 190,000; Full time

Job summary

Ventures Unlimited, Inc. seeks a skilled project leader to drive medical-device market expansion projects across the United States and international markets.

You will coordinate regulatory strategy, technical documentation, labeling localization, and manufacturing readiness while aligning cross-functional teams and senior leadership on critical milestones. Responsibilities include end-to-end planning, gap assessments, risk management, and governance reviews to ensure timely registration and

Qualifications

• Experience managing medical-device market expansion projects across countries.
• Proficient in creating project charters, scope, WBS, integrated schedules, critical-path analysis, resource planning, budget tracking, and governance reporting.
• Knowledge of ISO 13485, ISO 14971, FDA QMSR (21 CFR Part 820), EU MDR, and country-specific registrations.
• Coordinate Regulatory Affairs, QA, R&D, Clinical Affairs, Medical Affairs, Manufacturing, Supply Chain, and regional teams.
• Understand technical documentation and design records including DHF, risk management, V&V evidence, labeling, IFU, and packaging docs.
• Familiarity with PMCF activities and SSCP preparation.
• Experience managing risks, issues, dependencies, change control, and submission-readiness across multiple products and markets.
• Proficiency with scheduling and reporting tools such as Microsoft Project, Excel, and PowerPoint.
• Experience with orthopedic implants, surgical instruments, or other regulated medical-device portfolios.
• Exposure to regional regulatory submissions and notified-body review coordination.
• Familiarity with UDI, device registration, labeling localization, and PLM systems.
• Familiarity with Windchill PLM.
• Lead end-to-end planning and execution of medical-device market expansion projects.
• Develop and maintain an integrated project plan covering regulatory strategy, technical documentation, clinical evidence, labeling/localization, manufacturing and supply readiness, and launch dependencies.
• Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
• Manage schedules, resources, budget forecasts, risks, and dependencies; maintain logs and mitigations.
• Facilitate cross-functional meetings and governance reviews; communicate status, decisions, and actions.

Responsibilities

• Lead end-to-end planning and execution of medical-device market expansion projects.
• Develop and maintain an integrated project plan covering regulatory strategy and submissions, documentation, clinical evidence, labeling, localization, and manufacturing readiness.
• Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
• Manage schedules, resources, budgets, risks, and dependencies; maintain risk/issue/dependency logs with mitigations.
• Facilitate governance reviews and provide status updates and decisions to leadership.

Skills

Cross-functional leadership

Communication skills

Negotiation

Problem solving

Stakeholder management

Distributed teams

Tools

Microsoft Project

Excel

PowerPoint

Windchill

Job description

Ventures Unlimited, Inc. seeks a skilled project leader to drive medical-device market expansion projects across the United States and international markets.

You will coordinate regulatory strategy, technical documentation, labeling localization, and manufacturing readiness while aligning cross-functional teams and senior leadership on critical milestones. Responsibilities include end-to-end planning, gap assessments, risk management, and governance reviews to ensure timely registration and