EU MDR Project Lead – Medical Devices

Johnson & Johnson Co.; Ireland; Vor Ort; EUR 70.000 - 121.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Zusammenfassung

Johnson & Johnson’s Orthopedics division seeks a Principal Project Manager to develop and maintain schedules for MDR submissions. You will serve as the primary contact for Notified Bodies, guiding project planning to support timely reviews and franchise goals from Ringaskiddy, Cork, Ireland.

The role requires a Bachelor’s degree and 5–8 years of PM experience in medical devices; Master’s degree and PMP certification are preferred.

Qualifikationen

• Bachelor’s degree in project management, regulatory affairs, life sciences, engineering, or related field.
• Master’s degree preferred.
• 5–8 years of project management experience in medical devices or regulated environments.
• Experience managing cross-functional projects in medical devices.
• Strong planning, scheduling, and organizational skills.
• Excellent communication and stakeholder management.
• Proficiency in MS Office.

Aufgaben

• Coordinate submissions to EU Notified Bodies and track projects for new product introductions and changes.
• Liaise with business units to ensure proper submission execution.
• Develop and maintain detailed project plans, timelines, and reports for stakeholders.
• Identify risks and issues and implement mitigation plans.
• Maintain MDR Certificate data and documentation.
• Represent DePuy Synthes as the EU Notified Body liaison for MDR activities.
• Prepare outlines, summaries, status reports, memos, charts, and slides.
• Engage with EU regulatory personnel to expedite submissions.
• Facilitate relationships with Notified Bodies through recurring meetings.
• Prioritize EU regulatory filings with business units.
• Support continuous improvement of processes and project management practices.

Kenntnisse

Project management

Cross-functional teams

Regulatory affairs

Notified Bodies

English language

Stakeholder management

German language (plus)

Ausbildung

Bachelor's degree

Master's degree preferred

Tools

MS Office

Jobbeschreibung

Johnson & Johnson’s Orthopedics division seeks a Principal Project Manager to develop and maintain schedules for MDR submissions. You will serve as the primary contact for Notified Bodies, guiding project planning to support timely reviews and franchise goals from Ringaskiddy, Cork, Ireland.

The role requires a Bachelor’s degree and 5–8 years of PM experience in medical devices; Master’s degree and PMP certification are preferred.