Medical Device Project Manager

Tata Consultancy Services; West Chester (Chester County); Presencial; USD 100.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Supply Chain

Medical Device NPD

Educación

Bachelor of Computer Science

Herramientas

Microsoft Project

Excel

PowerPoint

Descripción del empleo

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 elevate 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, elevate issues promptly, and resolve conflicts.
• 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 & Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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