EUMDR Project Manager

This role leads a cross-functional team to implement the EU MDR requirements for the Arlington manufacturing site. The EU MDR project manager will lead the team in development and execution of the project management plan, identifies risks and mitigation strategies, and keeps stakeholders updated on progress. 

Position Responsibilities

• Leading a cross-functional team to implement EU MDR requirements.
• Developing and executing the project management plan.
• Identifying risks and mitigation strategies to address potential project challenges.
• Keeping stakeholders updated on project progress through regular communication.
• Directing, managing, and monitoring project activities to ensure alignment with objectives.
• Evaluating tradeoffs within the project to optimize outcomes.
• Meeting with project stakeholders to understand and refine the project scope.
• Reviewing project scope with the manager for approval and alignment.
• Creating a detailed Work Breakdown Structure to organize project tasks.
• Developing and managing the detailed project schedule.
• Analyzing the critical path and major workstreams to identify potential delays.
• Developing a risk management plan to proactively address project risks.
• Identifying, analyzing, and understanding potential project risks.
• Developing and monitoring a risk response plan to mitigate identified risks.
• Estimating, acquiring, and assigning resources for the project team.
• Defining roles, responsibilities, and deliverables for each team member.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field (advanced degrees preferred).
• Minimum of 5 years of project management experience in the medical device industry, with a focus on EU MDR or similar regulations.
• Strong understanding of regulatory requirements, risk analysis, and mitigation strategies under EU MDR.
• Expertise in developing and managing project schedules, Work Breakdown Structures (WBS), critical path analysis, and project risk plans.
• Demonstrated ability to lead cross-functional teams, facilitate stakeholder communications, and drive project execution.
• Excellent problem-solving, organizational, and communication skills.
• Familiarity with regulatory compliance tools and project management software.
• Knowledge of manufacturing processes and quality systems in a regulated environment.
• Previous success in managing on-site projects and coordinating cross-departmental efforts.