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
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.
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