Principal Project Manager – Medical Device Regulatory Projects

About the role

Johnson & Johnson’s Orthopedics division is seeking a Principal Project Manager to lead technical documentation and change notification submissions to EU Notified Bodies under the Medical Device Regulation (MDR). Based in Zuchwil, Switzerland, you will act as the primary liaison between DePuy Synthes and regulatory authorities, ensuring timely reviews and alignment with franchise goals.

Key responsibilities

• Coordinate all activities related to EU Notified Body submissions, including new product introductions and changes to existing products.
• Develop and maintain detailed project plans, timelines, and status reports for stakeholders and leadership.
• Identify project risks, implement mitigation strategies, and escalate issues as needed.
• Maintain MDR certificate data and associated documentation.
• Represent DePuy Synthes in interactions with EU Notified Bodies, preparing outlines, summaries, status reports, and presentation materials.
• Facilitate regular meetings with Notified Bodies and support continuous improvement of processes and systems.

Required profile

• Bachelor’s degree in project management, regulatory affairs, life sciences, engineering or related field (Master’s preferred).
• 5–8 years of project management experience in the medical device or regulated industry.
• Proven ability to manage cross‑functional projects and multiple priorities in a fast‑paced environment.
• Strong communication, collaboration, and stakeholder‑management skills.

Required skills

• Proficiency in MS Office.
• Project Management Professional (PMP) or similar certification (preferred).
• Fluent English (written and verbal); German is a plus.