Global Medical Device Market Expansion Lead

Volto Consulting; Raynham (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Volto Consulting in Raynham, MA is seeking a seasoned program manager to lead end-to-end medical-device market expansion projects. You will own project plans from initiation through registration and launch readiness, coordinating regulatory strategy, technical documentation, clinical evidence, labeling, localization, manufacturing readiness, and commercial launch dependencies.

The role requires cross-functional leadership across Regulatory Affairs, Quality, R&D, Clinical Affairs, Medical

Qualifications

• Experience managing medical-device market expansion projects, including registrations and launches.
• Proficient with project management artifacts: charters, scope definitions, WBS, schedules, risk, and governance reporting.
• Working knowledge of ISO 13485, ISO 14971, FDA QMSR 21 CFR Part 820, EU MDR and country registrations.
• Ability to coordinate cross-functional teams with clear ownership.
• Understanding DHF, risk management, and V&V evidence documentation.
• Experience with PMCF and post-market surveillance activities.
• Proficiency with MS Project, Excel and PowerPoint for scheduling and reporting.

Responsibilities

• Lead end-to-end planning and execution of medical-device market expansion projects, from initiation through registration and launch readiness.
• Develop and maintain an integrated project plan covering regulatory strategy, technical documentation, clinical evidence, labeling, localization, manufacturing readiness, and launch dependencies.
• 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 logs and mitigations.
• Facilitate cross-functional meetings and governance reviews; communicate status, decisions, and actions.

Skills

Project management

Cross-functional leadership

Regulatory strategy

Risk management

Communication

Negotiation

Scheduling and reporting

Problem solving

Tools

Microsoft Project

Excel

PowerPoint

Windchill

Job description

Volto Consulting in Raynham, MA is seeking a seasoned program manager to lead end-to-end medical-device market expansion projects. You will own project plans from initiation through registration and launch readiness, coordinating regulatory strategy, technical documentation, clinical evidence, labeling, localization, manufacturing readiness, and commercial launch dependencies.

The role requires cross-functional leadership across Regulatory Affairs, Quality, R&D, Clinical Affairs, Medical