Please find the requirements below and let me know if you are interested.
Title : Medical Device Project Manager
Location : Raritan, NJ (Onsite)
Employment Type : W2/C2C
Rate : $55/c2c or $49/w2
We are looking for an experienced Medical Device Project Manager to lead market expansion projects, managing the registration and launch of existing medical-device products across new countries and regions.
The role involves end-to-end project planning, regulatory coordination, documentation readiness, and cross-functional stakeholder management to ensure timely product registration and successful market launches.
Key Responsibilities:
· Lead medical-device market entry, expansion, product registration, and launch readiness projects.
· Develop and manage project plans, schedules, budgets, resources, and critical-path activities.
· Coordinate with Regulatory Affairs, QA, R&D, Clinical, Manufacturing, Supply Chain, and Commercial teams.
· Ensure readiness of technical documentation, DHF, risk management, labeling, IFU, and V&V records.
· Coordinate regulatory requirements and submissions related to EU MDR, FDA QMSR, ISO 13485, and ISO 14971.
· Manage project risks, issues, dependencies, change controls, and governance reporting.
· Track deliverables, facilitate stakeholder meetings, and provide regular project updates to leadership.
Required Skills:
· Experience in Medical Device Project Management and Market Expansion.
· Knowledge of EU MDR, FDA QMSR, ISO 13485, ISO 14971, and medical-device registration.
· Strong understanding of technical documentation and regulatory submissions.
· Proficiency in MS Project, Excel, and PowerPoint.
· Experience with orthopedic implants or surgical instruments is preferred.
· Familiarity with UDI, PLM tools (Windchill), and product lifecycle management is an advantage.
· PMP certification is preferred.
