EU MDR Project Lead – Medical Devices

Johnson & Johnson Co.; Churwell; On-site; GBP 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Project Manager to lead regulatory submissions and project planning for EU MDR in the Orthopedics division. You will coordinate cross-functional teams, manage timelines, and interact with Notified Bodies to support product approvals.

Ideal candidates have 5–8 years in medical devices, strong planning skills, and experience with Notified Bodies; English and German language skills are a plus.

Qualifications

• 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.

Responsibilities

• Coordinates activities concerned with submissions to EU Notified Bodies including applications and project tracking for new product introduction as well as for changes to existing products.
• Liaises with business units to ensure appropriate execution of submissions.
• Develops and maintains detailed project plans, timelines, and status reports for stakeholders and leadership.
• Identify project risks and issues, implement mitigation plans, and escape as appropriate.
• Coordinates maintenance of MDR Certificate data and associated documentation.
• Represents DePuy Synthes as point of contact for interactions with EU Notified Body with regards to MDR applications, change notifications, TD Assessments and for recurring project and business meetings.
• Establishes accountability for the preparation of necessary outlines, summaries, status reports memos, graphs, charts, tables, and slides.
• Interacts with EU regulatory agency personnel in order to expedite submission and approval of applications as necessary.
• Facilitates relationship building/maintenance with Notified Body by coordinating recurring connections (e.g. weekly, monthly, annual face-to-face meetings).
• Consults with business unit personnel to establish and prepare appropriate priorities for EU regulatory filings for product approvals.
• Supports continuous improvement initiatives by identifying opportunities to enhance processes, systems, and project management practices.

Skills

Project management

Regulatory affairs

Cross-functional collaboration

MS Office

Education

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

Master’s degree

Tools

MS Office

Job description

Johnson & Johnson is seeking a Principal Project Manager to lead regulatory submissions and project planning for EU MDR in the Orthopedics division. You will coordinate cross-functional teams, manage timelines, and interact with Notified Bodies to support product approvals.

Ideal candidates have 5–8 years in medical devices, strong planning skills, and experience with Notified Bodies; English and German language skills are a plus.