Principal Project Manager – MDR Submissions (Orthopedics)

Brighter Signals; Zuchwil; On-site; CHF 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Project Manager in Orthopedics to lead regulatory submissions and project planning across EU Notified Bodies. You will collaborate with cross-functional teams to ensure timely reviews and align with franchise goals in a regulated medical device environment.

You will manage multiple projects, develop detailed plans, and interact with regulatory authorities to expedite approvals.

Qualifications

• Requires a Bachelor’s degree in project management, regulatory affairs, life sciences, engineering, or related field.
• Master’s degree preferred for advanced roles.
• Typically 5–8 years of project management experience in medical devices or regulated environments.
• Strong planning, scheduling, and organizational skills; ability to manage multiple projects.

Responsibilities

• Coordinate submissions to EU Notified Bodies 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 implement mitigation plans; escalate when needed.
• Maintain MDR certificate data and related documentation.
• Represent the company in interactions with EU Notified Bodies and regulators.
• Prepare outlines, summaries, and slides for leadership and teams.
• Engage with regulatory authorities to expedite submissions and approvals.

Skills

Project management

Regulatory affairs

Cross-functional team

Communication

MS Office

Education

Bachelor's degree

Master's degree

Tools

MS Office

Job description

Johnson & Johnson is seeking a Principal Project Manager in Orthopedics to lead regulatory submissions and project planning across EU Notified Bodies. You will collaborate with cross-functional teams to ensure timely reviews and align with franchise goals in a regulated medical device environment.

You will manage multiple projects, develop detailed plans, and interact with regulatory authorities to expedite approvals.