EU MDR Project Lead - Medical Devices

Brighter Signals; West Yorkshire; On-site; GBP 90,000 - 130,000; Full time

Job summary

Johnson & Johnson’s Orthopedics unit, DePuy Synthes, seeks a Principal Project Manager to lead EU MDR submissions and cross-functional project planning. You will coordinate Notified Body activities, develop detailed project plans, and guide teams to timely reviews and milestone achievements.

You will interact with regulatory authorities, manage documentation, and drive continuous process improvements within a fast-paced, highly regulated environment in the United Kingdom and Europe.

Qualifications

• Languages: English (written and verbal) required; German (written and verbal) is a plus.
• Certifications: PMP or similar certification preferred.
• Bachelor’s degree required in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline.
• Master’s degree preferred.

Responsibilities

• Coordinates submissions to EU Notified Bodies and tracks project progress.
• Liaises with business units to ensure timely execution of submissions.
• Develops and maintains detailed project plans, timelines, and status reports.
• Identifies risks and issues, implements mitigations, and escalates as needed.
• Coordinates MDR certificate data and related documentation.
• Represents DePuy Synthes as the primary contact for Notified Body interactions on MDR applications and TD assessments.
• Prepares outlines, summaries, status reports, memos, graphs, and slides for stakeholders.
• Interacts with EU regulatory personnel to expedite submissions and approvals.
• Supports ongoing improvement of processes, systems, and project management practices.

Skills

Project management

Regulatory affairs

Cross-functional leadership

MS Office

Education

Bachelor's degree

Master's degree preferred

Tools

MS Office

Job description

Johnson & Johnson’s Orthopedics unit, DePuy Synthes, seeks a Principal Project Manager to lead EU MDR submissions and cross-functional project planning. You will coordinate Notified Body activities, develop detailed project plans, and guide teams to timely reviews and milestone achievements.

You will interact with regulatory authorities, manage documentation, and drive continuous process improvements within a fast-paced, highly regulated environment in the United Kingdom and Europe.