Principal Project Manager

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Project/Program Management Group

Job Sub Function: Project/Program Management

Job Category: Professional

All Job Posting Locations: Blackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom, West Yorkshire, England, United Kingdom

Job Description

About Orthopedics: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Principal Project Manager role.

Purpose:

The Principal Project Manager develops and maintains schedules and priorities for Technical Documentation and Change Notification submissions to Notified Bodies under Regulation (EU) 2017/745 (MDR). Serving as DePuy Synthes' primary point of contact for project planning and execution with Notified Body counterparts, this role provides business teams and Notified Body representatives with clear direction to support timely reviews and achievement of franchise goals.

• 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.

Qualifications and Requirements:

• Education Bachelor’s degree required in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline.
• Master’s degree preferred.

Experience and Skills Required:

• Typically requires 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
• Proficient in MS Office

Preferred:

• Experience in supporting new product development and/or product lifecycle management for medical devices.
• Previous experience in project management within a regulatory framework (e.g. submission projects with Notified Body)
• Solid understanding of European Medical Device framework, and quality systems
• Understanding of preparing, submitting, and maintaining regulatory filings and approvals.
• Excellent written, verbal and presentation skills including experience presenting at meetings with Regulatory Authorities.
• Experience working with global Regulatory Affairs teams and aligning local activities with global strategies.
• Experience using project management and collaboration tools
• Demonstrated ability to manage multiple priorities in a fast-paced environment.

Other:

• Languages: English (written and verbal) required. German (written and verbal) is a plus.
• Certifications: Project Management Professional (PMP) or similar certification preferred

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.