Principal Project Manager

Overview

In this role, you drive cross-functional project planning and execution to support EU MDR submissions and Notified Body interactions for DePuy Synthes. You partner with business units to align regulatory filings with franchise goals and maintain comprehensive project plans, risk management, and documentation. You will represent the company to Notified Bodies and regulators, accelerating approvals while improving processes. You join a fast-paced environment that values collaboration, regulatory acumen, and continuous improvement to enable safer, innovative medical devices.

Responsibilities

• Coordinate submissions to EU Notified Bodies including applications and project tracking for new product introductions and changes to existing products
• Liaise with business units to ensure proper execution of submissions
• Develop and maintain detailed project plans, timelines, and status reports for stakeholders and leadership
• Identify project risks and issues, implement mitigation plans, and escalate as needed
• Coordinate maintenance of MDR Certificate data and associated documentation
• Represent DePuy Synthes as the point of contact for interactions with EU Notified Body regarding MDR applications and TD Assessments
• Establish outlines, summaries, status reports, memos, graphs, charts, tables, and slides
• Interact with EU regulatory agency personnel to expedite submission and approval as necessary
• Facilitate relationship building with Notified Bodies through recurring meetings
• Consult with business units to set priorities for EU regulatory filings
• Support continuous improvement by identifying opportunities to enhance processes, systems, and project management practices

Key requirements

• Typically requires 5–8 years of experience in project management, preferably within Medical Device industry
• Proven experience managing cross-functional projects in a medical device or regulated environment
• Strong project planning, scheduling, and organizational skills
• Ability to manage multiple projects simultaneously and meet deadlines
• Strong communication, collaboration, and stakeholder management skills
• Proficient in MS Office
• Bachelor’s degree in project management, regulatory affairs, life sciences, engineering, or related scientific discipline

• Strong communication
• Collaboration
• Stakeholder management
• Project planning and scheduling
• Regulatory submissions and MDR knowledge
• Experience in regulated medical device environment

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