Senior Project Manager – MDR & Notified Body Submissions

Brighter Signals; Leeds; On-site; GBP 75,000 - 115,000; Full time

Job summary

Johnson & Johnson, a leader in healthcare, is seeking a Principal Project Manager for DePuy Synthes Orthopedics. You will develop and maintain schedules for MDR submissions to Notified Bodies and serve as the primary planning contact to ensure timely reviews and franchise goals.

You will coordinate EU submissions, manage risks, maintain MDR data, and liaise with business units and regulators. The role demands strong PM skills, regulatory knowledge, and excellent communication.

Qualifications

• 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 established deadlines.
• Strong communication, collaboration, and stakeholder management skills.
• Proficient in MS Office.

Responsibilities

• Coordinate submissions to EU Notified Bodies and track projects.
• Liaise with business units to ensure proper submission execution.
• Develop and maintain detailed project plans, timelines, and status reports.
• Identify risks and issues and implement mitigation plans.
• Coordinate maintenance of MDR Certificate data and documentation.
• Represent DePuy Synthes with EU Notified Bodies for MDR apps and meetings.
• Prepare outlines, summaries, memos, and slides.
• Interact with EU regulators to expedite submissions.
• Facilitate relationships with Notified Bodies through regular meetings.
• Prioritize EU regulatory filings for product approvals.
• Support continuous improvement of processes and PM practices.

Skills

Project management

Regulatory affairs

MS Office

Stakeholder management

Cross-functional collaboration

Education

Bachelor’s degree in project management, regulatory affairs, life sciences, engineering

Master’s degree

Tools

MS Office

Job description

Johnson & Johnson, a leader in healthcare, is seeking a Principal Project Manager for DePuy Synthes Orthopedics. You will develop and maintain schedules for MDR submissions to Notified Bodies and serve as the primary planning contact to ensure timely reviews and franchise goals.

You will coordinate EU submissions, manage risks, maintain MDR data, and liaise with business units and regulators. The role demands strong PM skills, regulatory knowledge, and excellent communication.