Medical Device Project Manager

Role: Project Manager

Required Skills: Supply Chain | Medical Device NPD

Qualification: BACHELOR OF COMPUTER SCIENCE

Experience: 8 - 16 Years

Function: TECHNOLOGY

Apply By: 2027-01-02

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

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• 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.

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