Senior MDR Submissions Project Manager

Brighter Signals; Basel; On-site; CHF 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Project Manager to develop and maintain schedules for MDR submissions and act as the primary liaison with EU Notified Bodies for DePuy Synthes. You will lead project planning and execution to support franchise goals across Orthopedics.

The role emphasizes cross-functional leadership, regulatory coordination, and rigorous stakeholder management in a fast-paced medical device environment.

Qualifications

• Typically requires 5–8 years of experience in project management.
• Experience managing cross-functional projects in medical devices/regulatory environment.
• Strong project planning, scheduling, and organizational skills.
• Excellent written and verbal communication and stakeholder management.

Responsibilities

• Coordinate EU Notified Bodies submissions including project tracking for new products and changes.
• Liaise with business units to ensure proper execution of submissions.
• Develop and maintain detailed project plans, timelines, and status reports.
• Identify risks and issues, implement mitigation plans, escalate as needed.
• Maintain MDR Certificate data and associated documentation.
• Represent DePuy Synthes as the point of contact with EU Notified Bodies for MDR matters.
• Prepare outlines, summaries, status memos, graphs, charts, and slides.
• Engage with EU regulatory personnel to expedite submissions.
• Foster relationships with Notified Body through regular contacts.
• Align regulatory filings priorities with business units; support process improvements.

Skills

Project planning

Scheduling

Stakeholder management

Communication

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s degree in PM/Regulatory

Master’s degree preferred

Tools

MS Office

Job description

Johnson & Johnson is seeking a Principal Project Manager to develop and maintain schedules for MDR submissions and act as the primary liaison with EU Notified Bodies for DePuy Synthes. You will lead project planning and execution to support franchise goals across Orthopedics.

The role emphasizes cross-functional leadership, regulatory coordination, and rigorous stakeholder management in a fast-paced medical device environment.