Principal MDR Submissions Lead & Notified Body Liaison

Johnson & Johnson Co.; Leeds; On-site; GBP 70,000 - 100,000; Full time

Job summary

Johnson & Johnson, through DePuy Synthes Orthopedics, seeks a Principal Project Manager to manage technical documentation and MDR submissions to Notified Bodies. You will act as the primary planning and execution contact, guiding teams toward timely reviews and franchise goals.

Responsibilities include developing project plans, coordinating with global regulatory colleagues, and maintaining smooth interactions with Notified Bodies.

Qualifications

• Bachelor's degree required in project management, regulatory affairs, life sciences, engineering, or related field.
• Master's degree preferred.

Responsibilities

• Coordinates submissions to EU Notified Bodies, including applications and project tracking for new product introductions and changes to existing products.
• Liaises with business units to ensure execution of submissions.
• Develops and maintains detailed project plans, timelines, and status reports for stakeholders and leadership.
• Identify project risks and issues, implement mitigation plans, and escalate as needed.
• Coordinates maintenance of MDR Certificate data and related documentation.
• Represents DePuy Synthes as the point of contact for interactions with EU Notified Bodies regarding MDR applications and notices.

Skills

Project management

Cross-functional leadership

Regulatory affairs

Communication

MS Office

Education

Bachelor's degree in project management or related

Master's degree

Tools

MS Office

Job description

Johnson & Johnson, through DePuy Synthes Orthopedics, seeks a Principal Project Manager to manage technical documentation and MDR submissions to Notified Bodies. You will act as the primary planning and execution contact, guiding teams toward timely reviews and franchise goals.

Responsibilities include developing project plans, coordinating with global regulatory colleagues, and maintaining smooth interactions with Notified Bodies.