EU MDR Lead - Principal Project Manager

Johnson & Johnson Co.; Ringaskiddy; On-site; EUR 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Ringaskiddy, Cork, Ireland invites a Principal Project Manager to lead regulatory submissions and project plans for orthopedic and medtech products. You will coordinate EU Notified Body interactions, maintain schedules, and drive cross-functional teams across regulatory, clinical, and QA activities.

Ideal candidates have 5–8 years in medical device project management, strong communication, and proven ability to manage multiple complex programs under MDR frameworks.

Qualifications

• 5–8 years of project management experience in medical devices.
• Experience managing cross-functional projects in regulated environments.
• Strong planning, scheduling, and organizational skills.
• Ability to manage multiple projects and meet deadlines.
• Excellent written and verbal communication.

Responsibilities

• Coordinates activities with EU Notified Bodies including applications and project tracking for new product introductions and changes.
• Liaises with business units to ensure proper execution of submissions.
• Develops and maintains detailed project plans, timelines, and status reports for stakeholders.
• Identifies project risks and issues, implements mitigation plans, and escalates as appropriate.
• Coordinates MDR certificate data and related documentation maintenance.
• Represents DePuy Synthes as the contact for EU Notified Body interactions on MDR apps, changes, and TD assessments.
• Establishes accountability for preparation of outlines, summaries, status reports, memos, graphs, tables, and slides.
• Interacts with EU regulatory personnel to expedite submissions and approvals as needed.
• Facilitates relationship-building with Notified Bodies via recurring meetings.
• Consults with business units to set priorities for EU regulatory filings.

Skills

Project management

Cross-functional coordination

Scheduling & planning

Stakeholder management

Regulatory knowledge

Communication

MS Office

Education

Bachelor's degree

Master's degree

Tools

MS Office

Job description

Johnson & Johnson Ringaskiddy, Cork, Ireland invites a Principal Project Manager to lead regulatory submissions and project plans for orthopedic and medtech products. You will coordinate EU Notified Body interactions, maintain schedules, and drive cross-functional teams across regulatory, clinical, and QA activities.

Ideal candidates have 5–8 years in medical device project management, strong communication, and proven ability to manage multiple complex programs under MDR frameworks.