Project Manager

We are seeking a dynamic and experienced Project Manager to lead our medical-device market expansion projects. This role involves managing the entry of existing products into new countries or regions and coordinating registration and launch readiness.

Key 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 escalate constraints with mitigation options.
• Facilitate cross-functional working meetings and governance reviews; communicate status, decisions, and actions.

Must-Have Technical/Functional Skills

• Experience managing medical-device market expansion projects.
• 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 (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.
• Understanding of technical documentation, design and development records, 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.

Desirable Skills

• Experience with orthopedic implants, surgical instruments, or other regulated medical-device portfolios.
• Exposure to regional regulatory submissions, notified-body review coordination.
• Familiarity with UDI and device registration, labeling localization, and product lifecycle management systems.
• Familiarity with PLM systems such as Windchill.

Generic Managerial Skills

• 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, escalate issues promptly, and resolve conflicts.
• Ability to coordinate geographically distributed teams and maintain accountability for agreed actions and deliverables.

Experience Required

6-8 years of relevant experience in project management within the medical device and regulations domain.

Work Assignment Location

Onsite

Keywords

• Medical Device Project Manager
• Market Expansion
• Market Entry
• Product Registration
• Launch Readiness
• Regulatory Affairs Coordination
• EU MDR
• FDA QMSR
• ISO 13485
• Technical Documentation
• DHF
• PMP