Project Manager - 587-1

Description and Requirements

Job Title : Project Manager Location : Tennessee, Arlington (Onsite) Employment Type : 12 months Pay Rate : $81/Hour
Position Overview:  We are seeking an experienced Project Manager to lead the implementation of European Union Medical Device Regulation (EU MDR) requirements at our Arlington manufacturing site. This role will be responsible for managing a cross-functional team, developing and executing project plans, identifying and mitigating risks, and ensuring successful project delivery within established timelines and budget constraints.
The Project Manager will serve as the primary point of coordination among stakeholders, facilitating communication across departments and driving project activities from initiation through completion. This is an individual contributor role that requires strong project leadership, sound judgment, and the ability to work independently with minimal supervision.

Key Responsibilities: 

• Lead the planning, execution, monitoring, and successful delivery of the EU MDR implementation project.
• Develop and maintain comprehensive project management plans, schedules, milestones, and deliverables.
• Coordinate and lead cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and other key stakeholders.
• Identify project risks, develop mitigation strategies, and proactively address issues that may impact project success.
• Monitor project performance, timelines, budgets, and resource allocation to ensure objectives are achieved.
• Organize and facilitate project meetings, status reviews, and stakeholder communications.
• Provide regular project updates, reports, and recommendations to leadership and key stakeholders.
• Ensure compliance with applicable EU MDR regulations and internal quality management system requirements.
• Manage project documentation, change controls, and project governance processes.
• Drive accountability among project team members and support effective decision-making throughout the project lifecycle.
• Collaborate with internal customers and department personnel to align project goals and business objectives.

Qualifications: 

• Bachelor’s degree in Business, Engineering, Life Sciences, Regulatory Affairs, Project Management, or a related field (or equivalent combination of education and experience).
• Minimum of 4 years of project management experience leading cross-functional initiatives.
• Experience managing projects from initiation through completion, including planning, execution, risk management, and stakeholder communication.
• Strong organizational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Demonstrated ability to work independently and manage multiple priorities in a fast-paced environment.
• Proficiency with project management tools and methodologies. 

Preferred

• Experience in the medical device, healthcare, pharmaceutical, or regulated manufacturing industry.
• Knowledge of EU Medical Device Regulation (EU MDR) requirements.
• Experience with regulatory compliance, quality systems, or product lifecycle management projects.
• Project Management certification (PMP, PRINCE2, or equivalent) is a plus.

Key Competencies

• Project Planning & Execution
• Risk Management
• Cross-Functional Leadership
• Stakeholder Management
• Regulatory Compliance
• Budget & Resource Management
• Change Management
• Strategic Communication
• Problem Solving & Decision Making
• Attention to Detail