New

Medical Device Project Manager

Tata Consultancy Services
$100,000 - $120,000
sick time, 401(k)
United States, Pennsylvania, West Chester
Nov 04, 2026
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 escalate 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, escalate issues promptly, and resolve conflicts. < /div> * Ability to coordinate geographically distributed teams and maintain accountability for agreed actions and deliverables Salary Range: $100,000-$120,000 a year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1 Location West Chester, PA Function TECHNOLOGY Role Project Manager ID 438304 Skills Supply Chain \| Medical Device NPD Salary Range $100,000 - $120,000 Desired Candidate Profile Qualifications BACHELOR OF COMPUTER SCIENCE