MDR Submissions Lead – Medical Devices

Brighter Signals; Lancashire; On-site; GBP 70,000 - 110,000; Full time

Job summary

Johnson & Johnson, a leader in health care, seeks a Principal Project Manager for Orthopedics. You will lead regulatory submissions, coordinate Notified Body interactions, and drive cross‑functional alignment to achieve MDR milestones.

With 5–8 years in medical device project management and strong regulatory know‑how, you will guide plans, timelines, and risk mitigation while collaborating with global teams and stakeholders to deliver compliant, timely solutions.

Qualifications

• Typically requires 5–8 years of project management experience in medical devices or regulated environments.
• Strong planning, scheduling, and organizational skills with ability to manage multiple projects.
• Excellent written, verbal and stakeholder management skills, plus regulatory filing experience.

Responsibilities

• Coordinate submissions to EU Notified Bodies and track projects for new product introductions or changes.
• Liaise with business units to ensure timely execution of submissions.
• Develop and maintain detailed project plans, timelines, and status reports for stakeholders.
• Identify risks and issues, implement mitigation plans, and escalate as needed.
• Maintain MDR certificate data and related documentation.
• Serve as DePuy Synthes contact for Notified Body interactions on MDR applications and TD assessments.
• Prepare outlines, summaries, memos, graphs, tables, and slides as required.
• Engage with EU regulatory personnel to expedite submissions and approvals.
• Build and maintain relationships with Notified Body through regular meetings.
• Assist in prioritizing EU regulatory filings for product approvals.
• Support continuous process improvement across regulatory project management.

Skills

Project management

Regulatory affairs

Cross‑functional collaboration

MS Office

Education

Bachelor's degree

Master's degree preferred

Tools

MS Office

Job description

Johnson & Johnson, a leader in health care, seeks a Principal Project Manager for Orthopedics. You will lead regulatory submissions, coordinate Notified Body interactions, and drive cross‑functional alignment to achieve MDR milestones.

With 5–8 years in medical device project management and strong regulatory know‑how, you will guide plans, timelines, and risk mitigation while collaborating with global teams and stakeholders to deliver compliant, timely solutions.