Medical Device Project Manager

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.