Global Medical Device Market Expansion Project Lead

Tata Consultancy Services Limited; West Chester (Chester County); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Discretionary Annual Incentive.

Comprehensive Medical Coverage: Health

Family Support: Parental Leaves

Insurance Options: Auto & Home

Commuter Benefits & Training Reimburse

Vacation, Time Off, Holidays

401K Plan, Bonus, College Fund, Loan

Job summary

Tata Consultancy Services in West Chester, PA is seeking a Project Manager to lead end-to-end medical-device market expansion initiatives. You will drive planning, regulatory strategy, and cross-functional collaboration across Regulatory Affairs, Quality, R&D, Clinical, Medical Affairs, and Manufacturing.

The role requires experience with entry of products into new markets, plus strong scheduling and governance skills.

Qualifications

• 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 QMSR (21 CFR Part 820), EU MDR, and country-specific registration requirements for target markets.
• Coordinate Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Medical Affairs, Manufacturing, Supply Chain, and regional commercial teams with clear deliverable ownership.
• Understand technical documentation and design records, DHF documentation, risk management, verification/validation evidence, labeling, use instructions, packaging documentation.
• Understand post-market surveillance and PMCF activities, and SSCP preparation.

Responsibilities

• Lead end-to-end planning and execution of medical-device market expansion projects, from initiation and market 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 readiness, and launch dependencies.
• Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical, and Medical Affairs.
• Manage schedules, resources, budgets, and critical-path dependencies; maintain risk logs and propose mitigations.
• Facilitate cross-functional meetings and governance reviews; communicate status, decisions, and actions.

Skills

Supply Chain

Medical Device NPD

Education

Bachelor of Computer Science

Tools

Microsoft Project

Excel

PowerPoint

Job description

Tata Consultancy Services in West Chester, PA is seeking a Project Manager to lead end-to-end medical-device market expansion initiatives. You will drive planning, regulatory strategy, and cross-functional collaboration across Regulatory Affairs, Quality, R&D, Clinical, Medical Affairs, and Manufacturing.

The role requires experience with entry of products into new markets, plus strong scheduling and governance skills.