Project Manager

Project Manager, EU MDR

12-month contract

Redmond, WA

Responsibilities:

• The primary responsibility of the EU MDR Project Manager is to use project management techniques to plan and execute labeling remediation projects for our products. This project manager will be responsible for multiple projects through the change management process to meet launch deadlines within a regulated medical device environment.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale
• Measure project performance, using appropriate tools and techniques, in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders
• Oversight of required changes and implementation processes, coordinating cross functional interactions, and driving timelines to meet business needs with stakeholders from Planning, Procurement, Manufacturing, Regulatory, Quality, Compliance, and Marketing
• Accountability to deliver complete labeling deliverables on time, in accordance with established procedures and within the specifications, including translations, if applicable
• Create a master labeling plan and schedule for new product development and change requests
• Manage documenting inputs for labeling and artwork projects and facilitate design reviews, as required

Qualifications:

• 4 years’ relevant regulatory or project management or equivalent combination of education and experience
• Project management training with professional certification (eg, PMP) is preferred
• Ability to generate and explain detailed proposals, schedules, objectives, and other documentation accurately
• Knowledge of design control, change control, and product labeling requirements in the medical device industry is strongly preferred
• Knowledge of FDA, ISO, and EN labeling requirements
• Knowledge of EU MDR requirements is preferred
• Experience in launching new or updated products, redesigns, line extensions or maintenance items in a medical device, food, or pharma company