Senior EU MDR Submissions Lead

Johnson & Johnson Services; Lancashire; On-site; GBP 70,000 - 110,000; Full time

Job summary

Johnson & Johnson in the UK (DePuy Synthes orthopedics) seeks a Principal Project Manager to lead European MDR submissions and Notified Body interactions. You will own schedules, risk and issue management, and ensure alignment of regulatory filings with franchise objectives.

Responsibilities include coordinating cross‑functional submissions, maintaining detailed project plans, and representing the company in regulatory meetings.

Qualifications

• Bachelor’s degree in project management, regulatory affairs, life sciences, engineering, or related field.
• Master’s degree preferred.
• Typically 5–8 years of experience in project management, preferably in 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 and meet deadlines.
• Strong communication, collaboration and stakeholder management skills.
• Proficient in MS Office.

Responsibilities

• Coordinate activities with EU Notified Bodies for submissions and project tracking.
• Liaise with business units to ensure proper execution of submissions.
• Develop and maintain detailed project plans, timelines, and status reports.
• Identify risks and issues; implement mitigation plans and escalate as needed.
• Maintain MDR Certificate data and documentation; represent DePuy Synthes in Notified Body interactions.
• Prepare outlines, summaries, status reports, memos, graphs, charts and slides.

Skills

Project planning

Scheduling

Stakeholder management

Communication

MS Office

Education

Bachelor's degree in project management/regulatory affairs/life sciences/engineering

Master’s degree preferred

Tools

MS Office

Job description

Johnson & Johnson in the UK (DePuy Synthes orthopedics) seeks a Principal Project Manager to lead European MDR submissions and Notified Body interactions. You will own schedules, risk and issue management, and ensure alignment of regulatory filings with franchise objectives.

Responsibilities include coordinating cross‑functional submissions, maintaining detailed project plans, and representing the company in regulatory meetings.