Principal Project Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

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

• 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 escalate 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.