Project Manager
Talent Software Services, Inc. · Posted Nov 6, 2026
- Raritan, New Jersey, United States
- On-site
- Full-time · Senior
- 6–8 years
Lead medical-device market expansion projects, including product entry, registration, and launch readiness coordination.
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.
Requirements
- Nice to have: orthopedic implants
- Nice to have: surgical instruments
- Nice to have: regional regulatory submissions
- Nice to have: notified-body review coordination
- Nice to have: UDI