Project Management

About the role

Lead the implementation of European Union Medical Device Regulation (EU MDR) requirements for the Arlington manufacturing site. Manage a cross-functional team consisting of Regulatory Affairs, Quality, Manufacturing, Engineering, and Operations stakeholders. Develop, execute, and maintain comprehensive project plans, timelines, budgets, and resource allocations. Identify project risks, develop mitigation strategies, and proactively resolve issues to ensure project success. Monitor project progress and provide regular status updates to leadership and key stakeholders. Facilitate project meetings and drive accountability for achieving milestones and deliverables. Ensure project activities are completed on schedule and within budget while meeting regulatory requirements. Coordinate communication across departments to support effective collaboration and timely decision-making. Support compliance initiatives by ensuring alignment with EU MDR requirements and quality system standards. Maintain project documentation and ensure accuracy of records related to project execution and compliance activities. Work independently with minimal supervision while applying professional judgment and expertise to resolve complex issues. Drive continuous improvement and process optimization throughout the project lifecycle. Serve as the primary point of contact for project stakeholders, ensuring transparency, alignment, and successful project outcomes. Utilize strong analytical, organizational, and problem-solving skills to manage multiple priorities in a regulated environment.

Responsibilities

• Lead the implementation of European Union Medical Device Regulation (EU MDR) requirements for the Arlington manufacturing site.
• Manage a cross-functional team consisting of Regulatory Affairs, Quality, Manufacturing, Engineering, and Operations stakeholders.
• Develop, execute, and maintain comprehensive project plans, timelines, budgets, and resource allocations.
• Identify project risks, develop mitigation strategies, and proactively resolve issues to ensure project success.
• Maintain project documentation and ensure accuracy of records related to project execution and compliance activities.
• Coordinate communication across departments to support effective collaboration and timely decision-making.
• Support compliance initiatives by ensuring alignment with EU MDR requirements and quality system standards.
• Utilize strong analytical, organizational, and problem-solving skills to manage multiple priorities in a regulated environment.

Requirements

• Minimum of 4+ years of project management experience in a regulated industry.
• Experience leading cross-functional projects involving Quality, Regulatory Affairs, Manufacturing, Engineering, and Operations.
• Demonstrated experience with EU Medical Device Regulation (EU MDR) implementation, remediation, or compliance activities.
• Strong understanding of medical device regulatory requirements and quality systems.
• Experience developing and executing project plans, schedules, budgets, and resource allocations.
• Proven ability to identify project risks and develop effective mitigation strategies.
• Experience managing project timelines, milestones, and deliverables across multiple stakeholders.
• Ability to independently lead complex projects with minimal supervision.
• Strong analytical and problem-solving skills with attention to detail.
• Experience preparing and delivering project status updates to senior leadership.
• Knowledge of change management principles within regulated environments.
• Excellent written, verbal, and presentation communication skills.
• Strong organizational and time-management abilities.
• Proficiency with project management tools such as Microsoft Project, Smartsheet, Jira, or similar platforms.
• Ability to influence cross-functional teams without direct reporting authority.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, Business, or a related field.

Skills

• Analysis
• Project Management
• Technical Experience

Benefits

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