Medical Device Project Manager

VOLTO Consulting; Raynham (MA); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Project management

Cross-functional leadership

Regulatory strategy

Risk management

Communication

Negotiation

Scheduling and reporting

Problem solving

Herramientas

Microsoft Project

Excel

PowerPoint

Windchill

Descripción del empleo

Fulltime

Job Description

Must Have Technical/Functional Skills

• Experience managing medical-device market expansion projects, including entry of existing products into new countries or regions and coordination of registration and launch readiness.
• Proficiency in project charters, scope definition, work breakdown structures, integrated schedules, critical-path analysis, resource planning, budget tracking, and governance reporting.
• Working knowledge of ISO 13485, ISO 14971, FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), EU MDR, and country-specific registration requirements relevant to the target markets.
• Ability to coordinate Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Medical Affairs, Manufacturing, Supply Chain, and regional commercial teams, with clear deliverable ownership.
• Understanding technical documentation and design and development records, including DHF documentation where used, risk management, verification and validation evidence, labeling, instructions for use, and packaging documentation.
• Understanding post-market surveillance and PMCF activities, and SSCP preparation.
• Experience managing risks, assumptions, issues, dependencies, change control, document review cycles, and submission-readiness across multiple products and markets.
• Proficiency in project scheduling and reporting tools such as Microsoft Project, Excel, and PowerPoint.

Desirable

• 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 and device registration, labelling localization, and product lifecycle management systems.
• Familiarity with a PLM system such as Windchill.

Roles & Responsibilities

• Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration and launch readiness.
• Develop and maintain an integrated project plan covering regulatory strategy and submissions, technical documentation, clinical evidence, labeling and localization, manufacturing and supply readiness, and commercial launch dependencies.
• Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
• Manage schedules, resources, budget forecasts, and critical-path dependencies; maintain risks, assumptions, issues, and dependencies logs and escalated constraints with mitigation options.
• Facilitate cross-functional working meetings and governance reviews; communicate status, decisions, and actions.

Generic Managerial Skills, If any

• Strong cross-functional leadership and ability to influence stakeholders in an organization.
• Strong written and verbal communication skills, with the ability to provide clear, concise updates to senior leadership, facilitate meetings, and accurately document key decisions.
• Ability to negotiate with stakeholders to secure the required resources and adjust project plans when deadlines change.
• Ability to solve problems systematically, make decisions based on risk, escalated issues promptly, and resolve conflicts.
• Ability to coordinate geographically distributed teams and maintain accountability for agreed actions and deliverables.